FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1885258
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08407
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 28, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
FOLLOWING AN IMPLANT, IT WAS REPORTED THE PATIENT EXPERIENCED A BURNING SENSATION FROM THEIR DEVICE. HIGH IMPEDANCES OR >3,600 OHMS WERE ALSO REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA017007N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD017048N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# V003186| EXTENSION: MODEL 37083, LOT# NKC006936N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC006937N |