FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 3002616
·
Received March 13, 2013
Report
- Report Number
- 6000153-2013-00032
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 20, 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). FINAL ANALYSIS OF THE EXTENSION REVEALED NO SIGNIFICANT ANOMALY. THE EXTENSION BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODES NO LONGER APPLY TO THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS CUT DURING SURGERY AND THEREFORE WAS REPLACED BY ANOTHER ONE. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105966 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 37085-95 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |