FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1060646
·
Received June 13, 2008
Report
- Report Number
- 2182207-2008-03211
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- March 25, 2008
- Report Date
- May 15, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED GRABBING AND BANDING IN RIBS AND AROUND CHEST. THE PT ALSO REPORTS A PAINFUL POCKET AT ALL TIMES AND BURNING DYSESTHESIA WHEN IPG IS ON. THE PT HAS HAD A REVISION IN THE PAST WITH POSITIVE RESULTS FOR SEVERAL MONTHS, BUT NOTED AN INCREASED TENDERNESS IN THE POCKET SINCE THE SURGERY. THE PT WAS FRUSTRATED AND REQUESTING REMOVAL OF THE SYSTEM. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MEDTRONIC NEUROMODULATION | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3487A LOT# V047836 IMPLANTED| EXPLANTED| EXTENSION MODEL 37082 LOT# NKB007166N IMPLANTED| ACCESSORY MODEL 37752 LOT# NKA027036N IMPLANTED| LEAD MODEL 3487A LOT# V026801 IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD039386N IMPLANTED |