FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1161189
·
Received September 15, 2008
Report
- Report Number
- 3004209178-2008-05765
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- June 1, 2008
- Report Date
- August 19, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S STIMULATION DEVICE WAS REMOVED DUE TO INFECTION. NO SPECIFIC SYMPTOMS WERE REPORTED. THE HCP INDICATED THERE WAS NO FURTHER INJURY TO THE PATIENT.
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 | Required Intervention | IMPLANTED:| IMPLANTED:| LEAD MODEL 3998 LOT# L84002| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7495-51 LOT# XR0076677N| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7495-51 LOT# XR0076676N |