FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 3883744
·
Received June 19, 2014
Report
- Report Number
- 6000153-2014-00120
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 31, 2014
- Report Date
- May 31, 2014
- Manufacturer
- NEURO - VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE LEAD FOUND ALL CONDUCTOR COILS WERE CRUSHED 9.7CM FROM THE DISTAL END.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THERAPY WAS EFFECTIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE IT WAS FOUND THE ¿MIDDLE PART OF THE LEAD WAS BENT AFTER REMOVING THE GUIDE.¿ IT WAS STATED THE LEAD WAS REPLACED AT THAT TIME. IT WAS NOTED THERE WERE ¿NO¿ PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PHYSICIAN USED A BURR HOLE RING AND CAP DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361728 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3389-40 | 0208107756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |