FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1083209
·
Received July 24, 2008
Report
- Report Number
- 3004209178-2008-04311
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 24, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE INS WAS FLIPPED. X-RAY CONFIRMED THE FLIP AND ALSO NOTED THE "LEADS ARE COMING OUT GOING COUNTER CLOCKWISE". NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | EXPLANTED:| EXPLANTED:| LEAD: MODEL 3887| LEAD: MODEL 3887| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083 LOT# NKC015229N IMPLANTED:| EXTENSION MODEL 37083 |