FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1130884
·
Received August 21, 2008
Report
- Report Number
- 3004209178-2008-05141
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S LEADS WERE OUT OF PLACE AND A REVISION WOULD BE NEEDED. THE PT WAS EXPERIENCING "TERRIBLE PAIN". THE PT HAD SEEN THEIR HEALTH CARE PROVIDER AND WAS WAITING FOR A SCHEDULED SURGERY DATE. ADD'L INFO INDICATED THE EXACT DATE OF SURGERY WAS UNK, BUT IT WAS THOUGHT THE PT UNDERWENT REVISION SURGERY 2008. THE MFR'S DEVICE TRACKING SYS INDICATED THE ENTIRE DEVICE SYS HAD BEEN REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| LEAD MODEL 3777| PROGRAMMER MODEL 37742| EXPLANTED| ACCESSORY MODEL 37752| LEAD MODEL 3777 |