FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 1888545
·
Received October 18, 2010
Report
- Report Number
- 3004209178-2010-08035
- Event Type
- Malfunction
- Date Received
- October 18, 2010
- Report Date
- September 20, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PT REPORTED HEADACHE SYMPTOMS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS INCIDENT. UNIPOLAR PAIRS FOR R SIDE WEREN'T ABLE TO BE LISTED ON FORM CASE & 8 = 3420, CASE & 9 = 1738, CASE & 10 = 1772, CASE & 11 = 3162. ADDITIONAL INFO RECEIVED INDICATED. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA PC | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN005695V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN005384V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V398923| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V298954 |