FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 2955268
·
Received February 11, 2013
Report
- Report Number
- 6000153-2013-00015
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 24, 2013
- Report Date
- January 24, 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).
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS FOR THE LEAD REVEALED NO ANOMALY FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT INTRAOPERATIVE LEAD TESTING REVEALED "LOW" IMPEDANCES IMMEDIATELY AFTER INSERTION INTO THE BRAIN. TWO IMPEDANCE TESTS WERE TAKEN ABOUT 1 MINUTE APART FROM EACH OTHER AND THEY BOTH READ "LOW." THE IMPLANTING PHYSICIAN CHOSE TO REPLACE THE LEAD AND THE RESULTING IMPEDANCES WERE ALL WITHIN NORMAL RANGE. THE SURGERY RESUMED AS PLANNED. SYSTEM IMPEDANCES WERE TESTED FOR AND WERE FOUND TO BE WITHIN NORMAL RANGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58660 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3387S-40 | VA01K4Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR |