FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 2211052
·
Received August 5, 2011
Report
- Report Number
- 3004209178-2011-06097
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Report Date
- July 14, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S DEVICE HAD NOT BEEN "WORKING AS EFFICIENTLY" AFTER MOVING TO A LIVING ASSISTANCE FACILITY. WHEN THE PT GOT CLOSE TO HER MICROWAVE SHE FELT "PULLING" ON HER LEADS. THE HEALTH CARE PROVIDER STATED THAT THE PT'S STRESS LEVEL AND ANXIETY INTERFERED WITH HER THERAPY. THE PT STATED THAT SHE FELT PRETTY MISERABLE. IT WAS ALSO REPORTED THAT AN MRI WAS CONDUCTED AND IT WAS DETERMINED THAT LEAD PLACEMENT WAS NOT A FACTOR IN THE DEVICE'S REPORTED LACK OF EFFICACY.
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 | LEAD: MODEL 3389S-40, LOT #V568687| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT #NJZ108003N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT #NKN005117V| LEAD: MODEL 3389S-40, LOT #V568687| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT #NKN002118V| EXPLANTED:| IMPLANTED: |