FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2220239
·
Received August 16, 2011
Report
- Report Number
- 6000032-2011-06438
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- July 6, 2007
- Report Date
- July 26, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REMOVED IN 2007 DUE TO AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., MED REL | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF008906N| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU025953V| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT032129P| EXPLANTED:| LEAD: MODEL 3890, LOT# J0337506V| EXPLANTED:| LEAD: MODEL 3487A, LOT# L54435 |