ACTIVA
Report
- Report Number
- 3004209178-2014-13970
- Event Type
- Injury
- Date Received
- August 5, 2014
- Report Date
- July 9, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY, BATTERY WAS AT END OF LIFE AND TELEMETRY WAS OK. BATTERY ANALYSIS DID NOT YIELD ANY UNUSUAL ELECTRICAL OR OTHER PROPERTIES FOR A BATTERY AT THIS STAGE OF DEPLETION. THE DATA GATHERED DURING THE REVIEW OF THE MANUFACTURING DATA, VISUAL AND DIMENSIONAL INSPECTION, AND ELECTRICAL TESTING DID NOT SHOW ANY ABNORMAL RESULTS. NO EVIDENCE OF AN INTERNAL MECHANISM FOR PREMATURE DEPLETION WAS FOUND DURING DESTRUCTIVE ANALYSIS.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-40, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3389-40, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-40, LOT# *UK6144407, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# *UK6144330, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3389-40, LOT# UNKNOWN, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# *UK6144330, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.
PRODUCT ID 3389-40, LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389-40, LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-40, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3389-40, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).
PRODUCT ID 3389-40, LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389-40, LOT# UNKNOWN, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).
IT WAS LATER REPORTED THAT IN THE BATTERY VOLTAGE CHART THE INS HAD 3 INCIDENTS OF RAPID BATTERY DEPLETION WHERE THE CURVE DROPPED SHARPLY. THE CHART INDICATED AN INTERMITTENT SHORT IN THE EXTENSION OR LEAD. ELECTRODES 0 AND 1 WERE THE ONLY ACTIVE ELECTRODES SO THE INTERMITTENT SHORT MUST HAVE BEEN BETWEEN THEM. PLACING THE PATIENT IN VARIOUS POSTURES INDICATED ANOTHER INTERMITTENT SHORT THAT COULD BE BETWEEN ELECTRODE 0 AND 2.
IT WAS LATER REPORTED THAT THE LEFT INS WAS BEING REPLACED ON THE DATE OF THIS REPORT. PRE-OPERATIVE IMPEDANCES ON THE LEFT INS AT 1.5V HAD SHOWN 2 SETS OF CONTACTS HAD HIGH VALUES. PRE-OPERATIVE IMPEDANCE VALUES WERE C/0-2708 OHMS AND C/1-2833 OHMS.
ADDITIONAL INFORMATION RECEIVED REPORTED THIS WAS NOT NORMAL BATTERY DEPLETION. THE DEVICE WAS USED WITHIN THE PATIENT FOR TREATMENT. THERE WAS NO PATIENT DEATH OR PATIENT INJURY. THE PATIENT HAD RECOVERED WITHOUT SEQUELA.
IT WAS LATER REPORTED THAT THE PATIENT HAD A SPINAL CORD STIMULATOR (SCS) TRIAL AND THE DEEP BRAIN STIMULATOR WENT TO END OF SERVICE AND THEY THOUGHT THERE MAY BE SOME RELATION SO THE DEVICE WAS SENT BACK FOR ANALYSIS. THERE WERE THREE DISTINCT STEPS WHERE THE BATTERY VOLTAGE HAD SUDDENLY DROPPED AS WELL AS A SUBSTANTIAL BATTERY BOUNCE BACK FROM 2.20V TO 2.83V AFTER EOS HAD OCCURRED. FOLLOWING EOS OCCURRING STIMULATION WAS PERMANENTLY OFF WHICH HAD TAKEN A LOAD OFF THE BATTERY ALLOWING THE VOLTAGE TO BOUNCE BACK. THERE WAS EVERY APPEARANCE OF AN INTERMITTENT SHORT WHICH HAD BECOME ACTIVE THREE TIMES. ONCE ON (B)(6) 2014, IT WAS NOT A HARD SHORT AND IT HAD CONTINUED TO AFFECT THE BATTERY UNTIL (B)(6) 2014. THE SECOND REOCCURRENCE WAS ON (B)(6) 2014, WHICH WAS A HARD SHORT AND HAD ONLY LAST ABOUT 1.5 HOURS AND IT HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). THE THIRD TIME WAS ON (B)(6) 2014 WHICH WAS ALSO A HARD SHORT AND HAD LASTED AT LEAST 3 HOURS AND WAS LONG ENOUGH TO TRIGGER EOS. THE BATTERY VOLTAGE CURVE INDICATED THAT WHEN THE SHORT HAD OCCURRED IT HAD VERY LOW IMPEDANCE VALUE AND WAS THEREFORE LIKELY FAIRLY CLOSE TO THE INS. THE INTERMITTENT SHORT APPEARED TO BETWEEN ELECTRODES 0 AND 1 WHICH WERE THE ACTIVE ELECTRODES.
IT WAS REPORTED THAT THERE WAS AN END OF SERVICE (EOS)/END OF LIFE (EOL) MESSAGE. THE PATIENT¿S LEFT IMPLANTABLE NEUROSTIMULATOR (INS) HAD GONE TO EOS PREMATURELY. IT WAS UNKNOWN WHEN THE DEVICE HAD ACTUALLY GONE TO EOS. PATIENT HAD HAD SEVERAL WEEKS PRIOR TO THE DATE OF THIS REPORT OF FEELING ¿CRAPPY¿ AND HAD HAD TROUBLE MOVING HIS LEGS/INITIATING MOVEMENTS, ETC. THE RIGHT SIDE OF THE BODY WAS THE WORST SYMPTOMATICALLY, WORSE THAN LEFT. IT WAS NOTED THAT THE PATIENT¿S TREMOR HAD NOT COME BACK FROM THE DEVICE GOING TO EOS. IMPEDANCE READINGS ON THE DATE OF THIS REPORT WERE C/0-2688, C/1-2374, C/2-1468, C/3-1255, 0/1-1596, 0/2-1468, 0/3-2630, 1/2 -1174, 1/3-2374 AND 2/3-1505. C/0 AND C/1 WERE NOT OUT OF RANGE WHEN PREVIOUSLY CHECKED AND NOW BOTH WERE GREATER THAN 2000 OHMS. LEFT PARAMETERS WERE 3.7V, 150USEC, 130HZ, 0-1+ AND 690 OHMS. IT WAS NOTED THAT IF IT WAS RUNNING 24 HOURS A DAY 7 DAYS A WEEK EOS WOULD BE EXPECTED AT 23.65 MONTHS. STIMULATION WAS INCREASED FROM 3.5V TO 3.7V IN APRIL PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THEY WERE LOWER ON THE LEFT IMPLANT THEN ON THE RIGHT IMPLANT. IT WAS LATER REPORTED THAT AN APPOINTMENT WAS SCHEDULED FOR THE PATIENT WITH THE NEUROSURGEON ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED SYMPTOMS PATIENT WAS EXPERIENCING INCLUDED WORSENING GAIT AND MOTOR FUNCTION. BATTERY DEPLETION WAS PREMATURE. A REPLACEMENT WAS PLANNED. THE PATIENT HAD NOT RECOVERED, SYMPTOMS/ISSUE WAS ONGOING. IT WAS NOTED THAT THE PATIENT HAD HAD A TRIAL FOR A PAIN STIMULATOR ABOUT 3 WEEKS PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THERE WAS AN INCREASE IN SYMPTOMS OVER SEVERAL WEEKS PRIOR TO (B)(6) 2014. IT WAS NOTED THAT THERE WAS IRRITATING MOVEMENT. NEURO EXAMINATION INCLUDED MONOTONIC AND ¿SI¿ HYPOPHONIC SPEECH. CENTRAL NERVOUS EXAMINATION SHOWED DECREASED ¿EXP¿, MOTOR. THERE WERE NO TREMORS AND NO DYSKINESIAS. THE PATIENT¿S GAIT INCLUDED ¿SI¿ DRAGGING OF THE RIGHT LEG AND THE PATIENT USED A CANE. RIGHT BATTERY ORIGINAL PARAMETERS WERE AMPLITUDE OF 3.9, 200PW, 160 RATE, 1-3+. LEFT BATTERY WAS AT END OF SERVICE. RIGHT WAS AT 2.88V. RIGHT THERAPY IMPEDANCE WAS 990OHMS, 3.999UA AND LEFT THERAPY IMPEDANCE WAS 690OHMS, 5.352UA. THE PLAN WAS TO GET A NEUROSURGERY CONSULT FOR BATTERY REPLACEMENT DUE TO UNEXPLAINED REASON FOR END OF SERVICE. IT SHOULD HAVE LASTED 23 MONTHS. ADDITIONAL INFORMATION WAS PROVIDED IN THIS DOCUMENT, SOME OF WHICH WAS ILLEGIBLE OR WAS UNABLE TO BE INTERPRETED DUE TO AN OBSTRUCTION ON THE DOCUMENT. A FOLLOW UP REPORT WILL BE SENT IF CLARIFICATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458541 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Required Intervention |