FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 2182315
·
Received July 11, 2011
Report
- Report Number
- 3004209178-2011-05310
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEALTH CARE PROVIDER RAN THE DEFAULT IMPEDANCE AND HIGH IMPEDANCE READINGS WERE SHOWN. THE HEALTHCARE PROVIDER BELIEVED THE LEADS NEEDED TO BE REPLACED. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT# 3004209178-2011-05311.
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 | 56 YR | PROGRAMMER: MODEL 37642 LOT# NJZ109808N| ADAPTER: MODEL 64001 LOT# N218038| LEAD: MODEL 3387S LOT# V020088| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S LOT# V020186| IMPLANTED:| EXTENSION: MODEL 7482 LOT# NHU142404V| IMPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NFW138453H| EXPLANTED:| ADAPTER: MODEL 64001 LOT# N259675| IMPLANTABLE NEURO STIMULATOR: MODEL 7426 |