FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1150392
·
Received September 5, 2008
Report
- Report Number
- 6000032-2008-05467
- Event Type
- Injury
- Date Received
- September 5, 2008
- Report Date
- August 6, 2008
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL, INC.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT EXPERIENCED SEVERE PAIN IN HIS BACK WHILE THE DEVICE IMPLANTED. IT TOOK THE PATIENT 7 YEARS TO FIND AN HCP TO EXPLANT THE DEVICE. THE DEVICE WAS DISPOSED OF BY THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL, INC. | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| IMPLANTED| IMPLANTED| IMPLANTED| LEAD MODEL 3887 LOT# J0008050V| EXTENSION MODEL 7495-51 LOT# XR0079997N| EXPLANTED| EXPLANTED| LEAD MODEL 3887 LOT# J0008050V| EXTENSION MODEL 7495-51 LOT# XR0073408N| EXPLANTED |