FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1080282
·
Received July 22, 2008
Report
- Report Number
- 3004209178-2008-04246
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 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
- MT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED AN ALLERGIC REACTION INCLUDING RED SKIN AT THE SITE OF THE ELECTRODES AT THE BASE OF THE SKULL, FOUR RED DOTS ON THE FOREHEAD, AND HIVES. IT WAS ALSO REPORTED THAT THE DEVICE "QUIT" WORKING SEVERAL MONTHS AGO. NO OUTCOME WAS REPORTED. 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 | SYNERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | IMPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3986A LOT # N0041337| EXTENSION MODEL 7489 LOT# NHU106092V| EXPLANTED| EXTENSION MODEL 7489 LOT#NHU106091V| IMPLANTED |