FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 2081440
·
Received April 22, 2011
Report
- Report Number
- 3004209178-2011-03011
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S DEVICE WAS IN A POWER ON RESET CONDITION (POR). IT WAS STATED THAT AFTER A PT PROGRAMMER INTERROGATION THE POR CONDITION WAS SEEN. THE PT THEN RE-INTERROGATED THEIR DEVICE, AND THE PROBLEM WAS RESOLVED. THERAPY WAS RESTORED AND THE PT RECOVERED WITHOUT SEQUELA.
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 | 23 YR | LEAD: MODEL 3389S-40, LOT# V398923| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN002242V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT# N186229| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC015030N |