ACTIVA
Report
- Report Number
- 3004209178-2014-11857
- Event Type
- Injury
- Date Received
- June 20, 2014
- Report Date
- June 17, 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 Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V836495, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V836495, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALY, THE INS HAD NORMAL END OF LIFE WITH TELEMETRY AND OUTPUT OKAY.
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THEY WERE DISSATISFIED WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) LONGEVITY PERFORMANCE OVERALL COMPARED TO THE LONGEVITY PERFORMANCE IN THE OLDER INS MODELS. IT WAS STATED IT DID NOT LAST AS LONG. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON THE DAY OF REPORT. IT WAS FURTHER REPORTED THE EXPLANT WAS COMPLETE. IT WAS NOTED IT WAS DUE TO PREMATURE BATTERY DEPLETION. IT WAS STATED IMPEDANCE TESTING WAS PERFORMED. IMPEDANCE RANGES: .7V LEFT: C<(>&<)>0 2095 C<(>&<)>1 1638 C<(>&<)>2 916 C<(>&<)>3 994 0<(>&<)>1 2508 0<(>&<)>2 2340 0<(>&<)>3 2517 1<(>&<)>2 1658 1<(>&<)>3 1959 2<(>&<)>3 1197 .7V RIGHT C<(>&<)>8 1276 C<(>&<)>9 2333 C<(>&<)>10 1034 C<(>&<)>11 923 8<(>&<)>9 2987 8<(>&<)>10 1825 8<(>&<)>11 1734 9<(>&<)>10 2640 9<(>&<)>11 2610 10<(>&<)>11 1392 IT WAS NOTED THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY AND THERE WERE NO PATIENT SYMPTOMS. IT WAS NOTED THE PATIENT WAS TOLD BY THEIR IMPLANTING PHYSICIAN THAT THE BATTERY WOULD LAST SEVERAL YEARS AND IT ONLY LASTED 9 MONTHS.
ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS USED WITHIN THE PATIENT FOR TREATMENT. THERE WAS NO PATIENT DEATH AND THE PATIENT HAD RECOVERED WITHOUT SEQUELAE. THE DEVICE WAS REPLACED ON (B)(6) 2014.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING GOOD AND THEY RECEIVED EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363596 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Required Intervention |