FDA Adverse Event
Injury
Summary report: N
SYNERGY PLUS+
MDR report key: 1101835
·
Received August 7, 2008
Report
- Report Number
- 3004209178-2008-04758
- Event Type
- Injury
- Date Received
- August 7, 2008
- Date of Event
- June 1, 2006
- Report Date
- July 10, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION; NO OTHER SYMPTOMS WERE REPORTED. THE DEVICE WAS NOT EXPLANTED AT THIS TIME, BUT WAS AT A LATER DATE (SEE MANUFACTURER'S REPORT# 300420917200700792).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY PLUS+ | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7479 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU120326V| EXTENSION MODEL 7489 LOT# NHU122924V| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 7439 LOT#NJD015866N| IMPLANTED:| LEAD MODEL 3999 LOT# V003770 |