UNKNOWN DEEP BRAIN STIMULATOR
Report
- Report Number
- 3007566237-2011-03721
- Event Type
- Injury
- Date Received
- May 20, 2011
- Date of Event
- October 1, 2009
- Report Date
- April 20, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME, NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) MAN DEVELOPED TARDIVE DYSTONIA FOLLOWING EXPOSURE TO A NEUROLEPTIC DRUG USED TO ADDRESS HIS SEVERE DEPRESSION. HE SUBSEQUENTLY UNDERWENT BILATERAL GPI DBS. PREOPERATIVELY, HE SUFFERED SEVERE AND PAINFUL RETROCOLLIC HEAD JERKS. POSTOPERATIVELY, HIS SUBJECTIVE PAIN AND HEAD JERKING CLINICALLY IMPROVED (PAIN APPROX 50% AND MOVEMENT DISORDERS APPROX 40-50%). SIX MONTHS FOLLOWING THE OPERATION THE BENEFITS WANED, AND A CT SCAN REVEALED THAT THE LEFT AND THE RIGHT LEADS HAD MIGRATED 15.6MM AND 4.6MM VENTRALLY FROM THEIR INITIAL POSITION. THE PT UNDERWENT SUCCESSFUL LEAD REPLACEMENTS. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. ONE MALE CHILD PT WITH GENERALIZED DYSTONIA HAD A LEAST ONE OF THE TWO IPG'S IMPLANTED IN THE CHEST RESET TO FACTORY DEFAULT STIMULATION SETTINGS PRESUMABLY DUE TO THE PROXIMITY OF THE IPG'S WITHIN 4 INCHES OF EACH OTHER WHEN THE PT LEANED FORWARD DURING PROGRAMMING, CAUSING CROSS-COMMUNICATION OF THE DEVICES. WHEN LYING SUPINE, THE DEVICES WERE 6 INCHES APART. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) WOMAN WITH A HISTORY OF ET WHO UNDERWENT A LEFT THALAMIC DBS IMPLANTATION THREE YRS PRIOR PRESENTED TO CLINIC WITH SUDDEN TREMOR RECURRENCE. A FEW DAYS BEFORE HER PRESENTATION, FOLLOWING A MAMMOGRAM, SHE EXPERIENCED A TINGLING SENSATION IN THE RIGHT UPPER EXTREMITY WITH AN ABRUPT LOSS OF BENEFIT IN HER RIGHT UPPER EXTREMITY TREMOR. WHEN THE DEVICE WAS CHECKED THE IMPEDANCE WAS DISCOVERED TO BE GREATER THAN 2000, AND A CHEST X-RAY REVEALED A FLIPPED IPG AND A TWISTED EXTENSION CABLE. A FRACTURE OF THE EXTENSION CABLE WAS SUSPECTED, AND REPLACEMENT OF THE CABLE RESOLVED THE ISSUE. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) MAN WITH A 16-YR-HISTORY OF PARKINSON'S DISEASE (PD) UNDERWENT UNILATERAL SUBTHALAMIC NUCLEUS (STN) LEAD IMPLANTATION. THERE WAS NO HISTORY OF HYPERTENSION, DIABETES MELLITUS, OR CORONARY ARTERY DISEASE. FOLLOWING THE PROCEDURE, HE BECAME SOMNOLENT, AND A POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A HEMATOMA IN THE LEFT LATERAL VENTRICLE. THERE WAS INVOLVEMENT OF THE THIRD VENTRICLE AND THE SYLVIAN AQUEDUCT. THE PT DEVELOPED ACUTE OBSTRUCTIVE HYDROCEPHALUS THAT NECESSITATED EMERGENT VENTRICULOSTOMY. HE CONVALESCED FOR ONE WEEK POSTOPERATIVELY, AND THEN DEVELOPED A DEEP VENOUS THROMBOSIS, AN ASPIRATION PNEUMONIA, ATRIAL FIBRILLATION, A URINARY TRACT INFECTION, AND SEPSIS. THE TOTAL HOSPITALIZATION WAS EXTENDED TO 40 POSTOPERATIVE DAYS. FOLLOWING EIGHT MONTHS OF REHABILITATION AND ANTICOAGURANT THERAPY, HE HAS RECOVERED, AND IMPLANTATION OF IMPLANTABLE PULSE GENERATOR (IPG) WAS SCHEDULED. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) MAN WITH PD UNDERWENT A STAGED UNILATERAL GLOBUS PALLIDUS INTERNA (GPI) DBS. HE WAS DISCHARGED ON POSTOPERATIVE DAY #1 FOLLOWING AN UNCOMPLICATED HOSPITAL COURSE, BUT LATER THAT DAY, HE BEGAN TO DEVELOP LEFT-SIDED WEAKNESS, LETHARGY, AND CONFUSION WHICH PEAKED ON POSTOPERATIVE DAY #2. HE PRESENTED TO THE EMERGENCY ROOM ON POSTOPERATIVE DAY #4. A HEAD CT SCAN REVEALED HEMORRHAGE SPREADING FROM THE CENTER OF THE DBS LEAD. THE REGION WAS SURROUNDED BY EDEMA. THE DIAGNOSIS OF VENOUS INFARCTION WAS MADE AND HE WAS CONSERVATIVELY MANAGED. FOLLOWING SEVERAL MONTHS, HIS NEUROLOGICAL STATUS RETURNED TO BASELINE, AND HIS DBS WAS EFFECTIVELY PROGRAMMED TO ADDRESS BOTH MOTOR FLUCTUATIONS AND PARKINSONISM. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) WOMAN WITH PD AND DEPRESSION WHO HAD A LEFT DBS IMPLANTATION TWO YRS PRIOR TO PRESENTATION WAS BROUGHT TO THE EMERGENCY ROOM FOLLOWING A SUICIDE ATTEMPT BY DRUG OVERDOSE. PASSIVE SUICIDAL IDEATION WAS NOTED ON HER PSYCHIATRIC EVAL PRIOR TO DBS. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) MALE WITH PD, CORONARY ARTERY DISEASE (PREVIOUSLY TREATED WITH ANGIOPLASTY), HYPERTENSION, DIABETES MELLITUS, AND HYPERLIPIDEMIA UNDERWENT UNILATERAL STN DBS PLACEMENT. AN IPG WAS PLACED FOUR WEEKS FOLLOWING THE DBS LEAD. FOLLOWING IPG IMPLANTATION, THE PT DIED IN HIS SLEEP ON POSTOPERATIVE DAY ONE FROM A MYOCARDIAL INFARCTION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) MAN WITH A NINE-YR-HISTORY OF PD UNDERWENT UNILATERAL STN DBS. HE ARRIVED FOR A ROUTINE CLINIC APPOINTMENT AND STAPLE REMOVAL ON POSTOPERATIVE DAY SEVENTEEN. FOLLOWING THE STAPLE REMOVAL, THERE WAS PURULENT DRAINAGE FROM THE CRANIAL INCISION SITE, AND THE PECTORAL INCISION REVEALED TENDER ERYTHEMA. HE WAS ADMITTED TO THE HOSPITAL URGENTLY, AND THE IPG AND THE EXTENSION WIRE WERE BOTH REMOVED. A COURSE OF INTRAVENOUS ANTIBIOTICS WAS COMPLETED PRIOR TO RE-IMPLANTATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) MAN WITH A HISTORY OF MEDICALLY REFRACTORY ESSENTIAL TREMOR (ET) UNDERWENT A UNILATERAL THALAMIC DBS IMPLANTATION. FOUR WEEKS FOLLOWING SURGERY, THE PT REPORTED TO THE CLINIC FOR ROUTINE F/U CARE. HEADACHE AND PROGRESSIVE DYSPHAGIA WERE THE CHIEF COMPLAINTS, AND A HEAD CT SCAN REVEALED A BRAIN ABSCESS ALONG THE DBS LEAD TRACT. THE CT SCAN DEMONSTRATED AN EDEMATOUS LESION SURROUNDING THE DBS LEAD WHICH WAS ENHANCED WITH CONTRAST MEDIA. HE WAS ADMITTED FOR EMERGENT CRANIOTOMY, DBS LEAD REMOVAL AND ABSCESS DRAINAGE. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
LITERATURE: MORISHITA T, FOOTE KD, BURDICK AP, ET AL. IDENTIFICATION AND MANAGEMENT OF DEEP BRAIN STIMULATION INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES. PARKINSONISM RELAT DISORD. 2010; 16(3):153-162. SUMMARY: THIS ARTICLE REVIEWED, IDENTIFIED, AND SUGGESTED MANAGEMENT STRATEGIES FOR BOTH INTRA- AND POSTOPERATIVE URGENCIES AND EMERGENCIES IN DEEP BRAIN STIMULATION (DBS) PTS, AND SEPARATED THE SCENARIOS INTO SURGERY/PROCEDURE RELATED; HARDWARE RELATED; STIMULATION-INDUCED DIFFICULTIES; AND OTHERS. TEN CASE STUDIES WERE INCLUDED FOR ILLUSTRATIVE PURPOSES. COMPLICATIONS WITH DBS-SPECIFIC MANIFESTATIONS WERE SELECTED AND A SEARCH WAS PERFORMED ON EACH ISSUE. THE CASE EXAMPLES WERE TAKEN FROM A DATABASE BETWEEN (B)(6) 2002 TO (B)(6) 2009. A (B)(6) BOY WITH DYT-1 POSITIVE GENERALIZED DYSTONIA UNDERWENT BILATERAL GPI DBS. AFTER AN INITIAL DRAMATIC RESPONSE, HIS BENEFIT DETERIORATED OVER THE FIRST YR. MEASUREMENT AND COMPARISON OF HIS DBS LEADS REVEALED DORSAL LEAD MIGRATION. HIS HEAD CIRCUMFERENCE WAS MEASURED AND FOUND TO BE 51.5 CM PREOPERATIVELY AND 53 CM 30 MONTHS LATER. REPOSITIONING THE DBS LEAD RECAPTURED BENEFITS. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE OR DYSTONIA EXPERIENCED A RETURNED OF NON-MOTOR SYMPTOMS UPON BATTERY "FAILURE," INCLUDING DEPRESSION AND SUICIDAL IDEATION. AN UNSPECIFIED NUMBER OF PTS WITH PARKINSON'S DISEASE AND DYSTONIA EXPERIENCED A RETURN OF MOTOR SYMPTOMS WITH BATTERY "FAILURE," INCLUDING TREMOR, GAIT PROBLEMS, AND STIFF LEGS. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL PTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Death| H| L| O| R | IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED: | |
| 10 | 26 YR | Death| H| L| O| R | IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK | |
| 11 | Death| H| L| O| R | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED: | ||
| 2 | 76 YR | Death| H| L| O| R | LEAD: MODEL UNK, LOT# UNK| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED: | |
| 3 | 73 YR | Death| H| L| O| R | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK | |
| 4 | 60 YR | Death| H| L| O| R | EXTENSION: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED: | |
| 5 | 54 YR | Death| H| L| O| R | EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| LEAD: MODEL UNK, LOT# UNK | |
| 6 | 58 YR | Death| H| L| O| R | IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED: | |
| 7 | 43 YR | Death| H| L| O| R | EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| EXPLANTED: | |
| 8 | 71 YR | Death| H| L| O| R | EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK | |
| 9 | 7 YR | Death| H| L| O| R | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED: |