FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 1841861
·
Received September 21, 2010
Report
- Report Number
- 3007566237-2010-07129
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- August 23, 2010
- Report Date
- August 23, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009/S05
- Adverse Event
- Yes
- 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 THAT THE CARRIER BROKE IN THE PT'S NECK AND THEY HAD TO MAKE ANOTHER INCISION. WHEN REMOVING THE EXTENSION, THE ELECTRODE WAS DESTROYED. DIFFERENT EXTENSIONS WERE USED AND EVERYTHING WAS OK AFTER THAT. PART OF THE CARRIER WAS SAVED. THE PT WAS STITCHED UP AND SURGERY WAS COMPLETED. THE PT'S STATUS WAS NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA PC | MHY | MEDTRONIC NEUROMODULATION | 37601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LEAD: MODEL 3387S, LOT#: V488644| EXTENSION: MODEL 37085, LOT#: NKN008329V| IMPLANTED:| EXTENSION: MODEL 37085, LOT#: NKN008330V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT#: V488644| IMPLANTED:| EXPLANTED:| EXPLANTED: |