FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 2981128
·
Received February 27, 2013
Report
- Report Number
- 6000153-2013-00023
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 3, 2013
- Report Date
- February 5, 2013
- 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
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BILATERAL NEUROSTIMULATOR IMPLANTATION "LEAD PACKAGE WAS OPENED AND THE STIMLOC WAS USED." WHEN A BUR HOLE WAS OPENED AND THE STIMLOC BASE WAS PLACED AND THEN THE SCREW WAS TIGHTENED UP, THE SCREW WRENCH BROKE. IT WAS DECIDED TO THEN USE ANOTHER NEW KIT. TEN DAYS LATER IT WAS STATED THAT PREVIOUSLY REPORTED INFORMATION WAS WRONG. IT WAS CONFIRMED THAT THE LEAD COULD NOT BE USED DUE TO THE BREAKAGE OF THE PERIPHERAL AREA OF THE STIMLOC SCREW AND NOT THE SCREW WRENCH. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84234 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |