FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 2244031
·
Received August 24, 2011
Report
- Report Number
- 3004209178-2011-06759
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 8, 2011
- Manufacturer
- MEDTRONIC 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
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE HEALTH CARE PROFESSIONAL REPORTED A LOW OUT OF RANGE IMPEDANCE VALUE OF 112 OHMS ON ELECTRODE PAIR 9 AND 11. IMPEDANCE READINGS WERE NORMAL ON ALL OTHER ELECTRODE PAIRS. THE POSSIBLE SHORT WAS PROGRAMMED AROUND. THE PATIENT WAS GETTING GOOD THERAPY RESULTS, THOUGH HE BUMPED HIS HEAD A LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA PC | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | EXTENSION: MODEL 37085, LOT# NKN016432V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN016431V| LEAD: MODEL 3387S-40, LOT# V670475| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S-40, LOT# V670475| PROGRAMMER: MODEL 37642, LOT# NJZ111426N| EXPLANTED: |