FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1853857
·
Received September 7, 2010
Report
- Report Number
- 2182207-2010-06803
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Report Date
- August 8, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS RECEIVING NO STIMULATION SENSATION. CALLER REPORTED IN VOICE MAIL THAT "STIMULATOR IS NOT WORKING". ADDITIONAL 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 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC NEUROMODULATION | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXTENSION: MODEL 37082, LOT# NKB005780V| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA141309N| PROGRAMMER: MODEL 37743, LOT# NKE147938N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3887, LOT# V120395| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB005475V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3887, LOT# V152776| LEAD: MODEL 3999, LOT# J0455119V| EXPLANTED:| EXPLANTED: |