FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1102563
·
Received August 8, 2008
Report
- Report Number
- 6000032-2008-04761
- Event Type
- Injury
- Date Received
- August 8, 2008
- Date of Event
- May 1, 2008
- Report Date
- July 10, 2008
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR REPROGRAMMING. THE DEVICE WAS REPROGRAMMED. THE PATIENT PROGRAMMER WAS REPLACED. THE PATIENT HAD OR WILL HAVE SURGERY TO FIX THE PROBLEM WITH THE DEVICE SYSTEM. THE PATIENT'S PROBLEMS WERE RELATED TO THE IMPLANTED SYSTEM.
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 | Required Intervention | EXPLANTED| LEAD MODEL 3890 LOT# J0315895V IMPLANTED| EXTENSION MODEL 7495-51 LOT# XR0078587N IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 7495-51 LOT# XR0081040N IMPLANTED| LEAD MODEL 3890 LOT# J0320212V IMPLANTED| EXPLANTED| PROGRAMMER MODEL 7435 LOT# NFT007492P |