FDA Adverse Event
Injury
Summary report: N
ACTIVA PC
MDR report key: 2181236
·
Received July 22, 2011
Report
- Report Number
- 3007566237-2011-05709
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- March 11, 2011
- Report Date
- June 28, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A SUCCESSFUL IMPLANTATION, BUT AFTER "SOME TIME", SKIN EROSION OCCURRED IN THE SUBCLAVICULAR AREA WHERE THE NEUROSTIMULATOR WAS IMPLANTED. THE PHYSICIAN BELIEVED THE EROSION MAY HAVE BEEN DUE TO THE SHARP EDGES OF THE NEUROSTIMULATOR. A REVISION OCCURRED ON (B)(6) 2011 TO REPOSITION THE DEVICE. THE PT WAS "BETTER" BUT THE PHYSICIAN WAS WORRIED SKIN EROSION MAY REOCCUR. IT WAS NOTED THAT NO PT INJURY OCCURRED. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | Required Intervention |