FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1090723
·
Received August 1, 2008
Report
- Report Number
- 3004209178-2008-04573
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- March 5, 2007
- Report Date
- July 1, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001/S42
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS FOR THE 7427, BOTH 7489 AND 3093 REVEALED NO ANOMALIES FOUND. THERE WERE NO DEVICE FAILURES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S IPG WOULD CONTINUOUSLY NOT STAY ON THE PROGRAMMED SETTINGS AND SHUT OFF. THE PATIENT HAD THE ENTIRE SYSTEM REPLACED. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.
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 | 25 YR | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION MODLE 7489 LOT# NHU131521V| LEAD MODEL 3093 LOT# V006813| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHYU131522V| LEAD MODEL 3093 LOT# V006813 |