ACTIVA
Report
- Report Number
- 3004209178-2015-20237
- Event Type
- Malfunction
- Date Received
- October 8, 2015
- Report Date
- October 5, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF THE DESKTOP CHARGER FOUND THE CONNECTOR WAS BROKEN AND THE CABLE ASSEMBLY WAS REPLACED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# VA0405A, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V961943, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).
A CONSUMER REPORTED THE CONNECTOR PIN ON THE DESKTOP CHARGER WAS BENT. THE PATIENT STARTED HAVING ISSUE WITH THE RECHARGER CONNECTING TO THE POWER SUPPLY IN (B)(6) 2015 AND THEY HAD NOTIFIED A MANUFACTURING REPRESENTATIVE AT THAT TIME. ON THE NIGHT PRIOR TO THIS REPORT, THE PATIENT TRIED CHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT THE RECHARGER WAS DEAD. THE INS BATTERY HAD DEPLETED AND SHUT OFF THE NIGHT PRIOR TO THIS REPORT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S INDICATION FOR USE IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670153 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR |