IMPLANTABLE NEUROSTIMULATOR
Report
- Report Number
- 2182207-2023-00093
- Event Type
- Injury
- Date Received
- January 15, 2023
- Date of Event
- April 19, 2022
- Report Date
- January 27, 2023
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389-40, LOT#: UNKNOWN, SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION, PRODUCT ID: NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED: EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3389-40, LOT#: UNKNOWN, SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION PRODUCT ID NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3389-40, LOT#: UNKNOWN ,SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED: , PRODUCT TYPE: EXTENSION PRODUCT ID NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3389-40, LOT#: UNKNOWN, SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION, PRODUCT ID: NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3389-40, LOT#: UNKNOWN, SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION PRODUCT ID NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3389-40, LOT#: UNKNOWN, SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION PRODUCT ID NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3389-40, LOT#: UNKNOWN, SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION, PRODUCT ID: NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3389-40, LOT#: UNKNOWN, SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION, PRODUCT ID: NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: NEU_INS_STIMULATOR, LOT#:, SERIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: LIBEN ZHANG, S., LIM, J., HO, S., CHEONG, E., PING LEE, G., WAN, K., NG, W., PEK, C. SAVING THE EXPOSED DEEP BRAIN STIMULATION IMPLANT: A COMPREHENSIVE REVIEW OF IMPLANT EXTRUSION AND RECONSTRUCTIVE OPTIONS. ANNALS OF PLASTIC SURGERY. VOLUME 89, NUMBER 6. 2022. DOI: 10.1097/SAP.0000000000003318. AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. EVENT: IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
LIBEN ZHANG, S., LIM, J., HO, S., CHEONG, E., PING LEE, G., WAN, K., NG, W., PEK, C. SAVING THE EXPOSED DEEP BRAIN STIMULATION IMPLANT: A COMPREHENSIVE REVIEW OF IMPLANT EXTRUSION AND RECONSTRUCTIVE OPTIONS. ANNALS OF PLASTIC SURGERY. VOLUME 89, NUMBER 6. 2022. DOI: 10.1097/SAP.0000000000003318. SUMMARY: INTRODUCTION: DEEP BRAIN STIMULATION (DBS) FOR THE TREATMENT OF PARKINSON DISEASE IS SUSCEPTIBLE TO COMPLICATIONS, SUCH AS HARDWARE EXTRUSION, MOST COMMONLY AT THE SCALP AND CHEST. THE AUTHORS DESCRIBE THEIR EXPERIENCE WITH THE MANAGEMENT OF HARDWARE EXTRUSION AND RECONSTRUCTION WITH ONE OF THE LARGEST SINGLE-INSTITUTION EXPERIENCE AND SUGGEST AN EVIDENCE-BASED TREATMENT ALGORITHM FOR THE MANAGEMENT OF SUCH CASES. METHODS: A RETROSPECTIVE REVIEW OF HOSPITAL RECORDS WAS PERFORMED TO IDENTIFY PATIENTS WHO UNDERWENT DBS-RELATED SURGERY AND RECONSTRUCTION FROM JANUARY 2015 TO APRIL 2020. MANAGEMENT OF THESE PATIENTS INVOLVED CULTURE-DIRECTED ANTIBIOTICS, LOCAL WOUND DEBRIDEMENT, VARIOUS FORMS OF RECONSTRUCTION, AND HARDWARE REMOVAL WHEN INDICATED. RESULTS: NINETY-FOUR PATIENTS WITH 131 DBS-RELATED PROCEDURES WERE INCLUDED. TWELVE PATIENTS (12.8%) HAD HARDWARE EXTRUSION, OF WHICH 6 OCCURRED PRIMARILY AT THE SCALP AND 6 OCCURRED PRIMARILY AT THE CHEST. PRIMARY CLOSURE OF SCALP WOUNDS (ODDS RATIO, 0.05[0.004¿0.71], P = 0.035) WAS NEGATIVELY ASSOCIATED WITH TREATMENT SUCCESS. THE TYPE OF RECONSTRUCTION OF CHEST WOUNDS DID NOT AFFECT ITS SUCCESS ( P = 0.58); HOWEVER, NONE OF THEM INVOLVED A NEW SURGICAL BED, SUCH AS CONTRALATERAL OR HYPOCHONDRIAL PLACEMENT. CONCLUSIONS: HARDWARE EXTRUSION IS A SIGN IFICANT COMPLICATION OF DBS-RELATED SURGERY. MANAGEMENT OF EXTRUSION AT THE SCALP SHOULD INVOLVE THE USE OF TENSION FREE, WELL-VASCULARIZED LOCOREGIONAL FLAPS AS OPPOSED TO PRIMARY CLOSURE. IMPLANTABLE PULSE GENERATOR EXTRUSIONS AT THE CHEST CAN BE MANAGED WITH BOTH PRIMARY CLOSURE AND REPOSITIONING IN A NEW SURGICAL BED. EXTRUDED DBS IMPLANTS MAY BE SALVAGED WITH APPROPRIATE RECONSTRUCTIVE CO NSIDERATIONS, AND THE AUTHORS SUGGEST AN EVIDENCE-BASED TREATMENT ALGORITHM. REPORTED EVENTS: 1. A 68 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED A SUBCLINICAL INFECTION 135 MONTHS AFTER INITIAL IMPLANTATION (15 AFTER THE LAST BATTERY CHANGED) AT THE VERTEX. THE BACTERIA P. ACNES WAS OBSERVED. TREATMENT AND RECONSTRUCTION INCLUDED PRIMARY CLOSURE AND THE PATIENT EXPERIENCED PERSISTENT INFECTION. FURTHER LOCAL MANAGEMENT INCLUDED ADVANCEMENT FLAP AND ULTIMATELY THE SALVAGE WAS A SUCCESS AT 162 MONTHS. 2. A 65 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED A RIGHT WIRE INFECTION (ABSCESS) 3 MONTHS AFTER INITIAL IMPLANTATION. PRIMARY CLOSURE WAS PERFORMED AND THE OUTCOME WAS PROXIMAL SPREAD. 5 MONTHS AFTER INITIAL IMPLANTATION THE INFECTION SPREAD FROM THE NECK TO THE POSTAURICULAR REGION. COAGULASE WAS FOUND. PRIMARY CLOSURE WAS THE TREATMENT AND THE OUTCOME WAS RECURRENT INFECTION AND PROXIMAL SPREAD. 15 MONTHS AFTER INITIAL IMPLANTATION IT SPREAD FROM THE NECK TO THE TEMPORAL REGION. LOCAL ADVANCEMENT FLAP WAS PERFORMED AND THE OUTCOME WAS PROXIMAL SPREAD. 30 MONTHS AFTER INITIAL IMPLANT THE INFECTION SPREAD TO THE PARIETAL REGION. THE BACTERIA P. ACNES WAS FOUND. PRIMARY CLOSURE OCCURRED AND THE OVERALL EVENT LED TO EXPLANTATION OF THE IMPLANTS AFTER 30 MONTHS. 3. A 66 YEAR OLD FEMALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED A LOCAL INFECTION AT THE FRONTAL WIRE 51 MONTHS AFTER INITIAL IMPLANTATION. COAGULASE WAS FOUND. PRIMARY CLOSURE WAS PERFORMED AND THE LOCAL RECURRENCE HAPPENED AT 109 AND 122 MONTHS. THEY REPEATED THE PRIMARY CLOSURE (109 MONTHS) AND THE PATIENT DECLINED REPEAT INTERVENTION AFTER RECURRENCE (122 MONTHS). THE WIRES REMAIN EXTRUDED AND THE PATIENT WAS CLINICALLY WELL AT 125 MONTHS. 4. A 53 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED A LOCAL INFECTION AT THE POSTAURICULAR REGION OF THE WIRE/CAP 120 MONTHS AFTER INITIAL IMPLANTATION (12 AFTER THE LAST BATTERY CHANGE). THE BACTERIA PSEUDOMONAS AERUGINOSA WAS OBSERVED. EXPLANTATION WITH PRIMARY CLOSURE WERE PERFORMED (AT 120 MONTHS). 5. A 60 YEAR OLD FEMALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED STITCH GRANULOMA AT THE POSTAURICULAR REGION OF THE WIRE 4 MONTHSAFTER INITIAL IMPLANTATION. THE BACTERIA METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS FOUND. PRIMARY CLOSURE WAS PERFORMED. THE OUTCOME WAS PERSISTENT INFECTION AND PROXIMAL SPREAD. THEY REPEATED PRIMARY CLOSURE AT 6 MONTHS AND PERFORMED A ROTATION FLAP AS WELL. 15 MONTHS AFTER INITIAL IMPLANTATION THE MRSA SPREAD TO THE TEMPORAL PORTION OF THE WIRE. ROTATION FLAP AND TEMPORALIS TRANSPOSITION FLAP WERE PERFORMED. THE OUTCOME WAS PROXIMAL SPREAD. AT 41 MONTHS THE MRSA THEN SPREAD TO THE PARIETAL REGION OF THE WIRE. EXPLANTATION WAS PERFORMED WITH ROTATION FLAP COVERAGE. THIS PATIENT ALSO EXPERIENCED IMPLANTABLE NEUROSTIMULATOR (INS) EXTRUSION AT THE CHEST. 23 MONTHS AFTER IMPLANTATION THE MRSA BACTERIA SPREAD FROM THE SCALP. THEY PERFORMED PRIMARY CLOSURE AND THE OUTCOME WAS RECURRENT EXTRUSION. AT 27 MONTHS THEY PERFORMED SUBPECTORAL INSERTION AND PRIMARY CLOSURE WITH THE OUTCOME BEING RECURRENT EXTRUSION. AT 35 MONTHS THEY PERFORMED PEDICLED LD MYOCUTANEOUS FLAP WITH THE OUTCOME BEING RECURRENT EXTRUSION. AT 38 MONTHS THEY PERFORMED A DBS IMPLANT REPLACEMENT AND PRIMARY CLOSURE. THE OUTCOME WAS THE SPREAD TO THE SCALP PREVIOUSLY STATED. ULTIMATELY THIS LED TO THE EXPLANTATION OF ALL PRODUCTS AT 41 MONTHS. 6. A 50 YEAR OLD FEMALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED A BACTERIAL INFECTION WHERE E. COLI WAS FOUND AT THE FRONTAL REGION OF THE WIRE WHICH HAD SPREAD FROM THE INS. THIS OCCURRED 65 MONTHS AFTER INITIAL IMPLANTATION. BILATERAL ADVANCEMENT FLAP WAS PERFORMED AND THE INFECTION SPREAD TO THE CAP. SCALP ADVANCEMENT WAS DONE AT 67 MONTHS AND EXPLANTATION ULTIMATELY OCCURRED. FOR THE INS AT 17 MONTHS THEY PERFORMED PERFORATOR-BASED ISLAND FLAP AND THE OUTCOME WAS RECURRENT EXTRUSION. AT 24 MONTHS A TRANSPOSITION FLAP WAS PERFORMED AND THE OUTCOME WAS RECURRENT EXTRUSION. AT 31 MONTHS A SUBCLINICAL INFECTION OCCURRED WHERE THE BACTERIA METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) WAS FOUND. TREATMENT INCLUDED LOCAL ADVANCEMENT FLAP AND THE OUTCOME WAS RECURRENT EXTRUSION. AT 33 MONTHS E. COLI WAS FOUND AND A PEDICAL VRAM FLAP WAS PERFORMED. OUTCOME WAS RECURRENT EXTRUSION. AT 43 MONTHS A LOCAL ADVANCEMENT FLAP WAS PERFORMED AND AT 45 MONTHS AN INS REPLACEMENT AND LOCAL ADVANCEMENT FLAP WERE PERFORMED. THIS SPREAD TO THE SCALP WHICH WAS STATED EARLIER. AT 67 MONTHS ALL IMPLANTS WERE EXPLANTED. 7. A 77 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED AN INFECTION 120 MONTHS AFTER INITIAL IMPLAN TATION AT THE PARIETAL WIRE. MRSA AND PROTEUS MIRABILIS, A. BAUMANNII (MRAB) SPREAD FROM THE INS. EXPLANTATION WITH PRIMARY CLOSURE OCCURRED. NO FURTHER EROSIONS OCCURRED. EXPLANTATION WAS AT 130 MONTHS. 8. A 55 YEAR OLD FEMALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED AN INFECTION 60 MONTHS AFTER IMPLANTATION (28 AFTER LAST BATTERY CHANGE). MSSA WAS FOUND AND THIS RESULTED IN EXPLANTATION. THE INFECTION SPREAD TO THE PARIETAL REGION OF THE WIRE/CAP. NO FURTHER EROSIONS OCCURRED. EXPLANTATION OCCURRED AT 60 MONTHS. 9. A 63 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED EXTRUSION AT THE INS SITE 45 MONTHS AFTER INITIAL IMPLANTATION (3 AFTER LAST BATTERY CHANGE). ADVANCEMENT FLAP (WITH SUBPECTORAL PLACEMENT AND TOTAL CAPSULECTOMY) WAS PERFORMED WITH NO FURTHER EROSIONS. THE SALVAGE WAS SUCCESSFUL AT 67 MONTHS. 10. A 64 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED AN INFECTION 2 MONTHS AFTER IMPLANTATION. MSSA WAS FOUND AND PRIMARY CLOSURE WAS PERFORMED. RECURRENT EROSION WAS THE OUTCOME. SUBPECTORAL INSERTION AND PRIMARY CLOSURE OCCURRED AT 3 MONTHS. THE SALVAGE WAS SUCCESSFUL AT 4 MONTHS. 11. A 59 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED AN INFECTION 63 MONTHS AFTER IMPLANTATION (3 AFTER THE LAST BATTERY CHANGE). MSSA WAS FOUND AND THEY PERFORMED PRIMARY CLOSURE. NO FURTHER EROSIONS OCCURRED AND THE SALVAGE WAS SUCCESSFUL AT 68 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1655922 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention | "SEE H10...." |