ACTIVA
Report
- Report Number
- 3004209178-2014-21583
- Event Type
- Malfunction
- Date Received
- November 14, 2014
- Report Date
- October 27, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY WAS AT NORMAL END OF LIFE AND TELEMETRY AND OUTPUT WERE OKAY.
(B)(4): PRODUCT ID: 37642: SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V865879, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4). 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.
IT WAS REPORTED THAT DURING THE PROCEDURE THE SCREW COVER ON THE DEVICE FELL OFF. THE COVER OVER THE SCREW WAS OFF AND WAS FOUND WITHIN THE POCKET. AN EXPLANT WAS REQUIRED AS A RESULT OF THE EVENT. IMPEDANCE TESTING WAS DONE. THE ISSUE WAS RESOLVED AND THE CAUSED WAS UNKNOWN. THIS WAS DURING A PREVIOUSLY SCHEDULED BATTERY CHANGE DUE TO END OF SERVICE, THE BATTERY AND THE BROKEN PART WAS EXPLANTED IN THE COURSE OF THE NORMAL PROCEDURE. THE PATIENT WAS ALIVE WITH NO INJURY. NO PATIENT SYMPTOMS WERE REPORTED. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737957 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00032 YR |