ACTIVA
Report
- Report Number
- 6000153-2013-00042
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- March 1, 2013
- Manufacturer
- NEURO - VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Removal / Correction Number
- Z-0185-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
FINAL ANALYSIS OF THE LEAD FOUND THE PROXIMAL END OF THE CONNECTOR WAS PULLED OUT OR OFF. FINAL ANALYSIS OF THE LEAD CAP FOUND NO ANOMALY.
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. POTENTIAL LEAD DAMAGE ASSOCIATED WITH THE DBS LEAD CAP (B)(6) 2013.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116023 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3389-40 | 0205813595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |