FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1083601
·
Received July 29, 2008
Report
- Report Number
- 3004209178-2008-04480
- Event Type
- Malfunction
- Date Received
- July 29, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 30, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT WAS RECHARGING MORE FREQUENTLY THAN EXPECTED. IMPEDANCE CHECKS REVEALED THAT ELECTRODE 1 AND 3 HAD IMPEDANCE READINGS OF LESS THAN 50 OHMS. THIS CAUSED A SHORT CIRCUIT, INCREASING THE CURRENT CONSUMPTION RESULTING IN THE BATTERY DISCHARGING FASTER THAN NORMAL. THE PT'S DEVICE WAS REPROGRAMMED AROUND THE NOTED SHORT CIRCUIT RESULTING IN ADEQUATE PAIN COVERAGE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | LEAD MODEL 3998 LOT#J0437133V| EXTENSION MODEL 7489 LOT#NHU068006V| EXPLANTED| PROGRAMMER MODEL 7435 LOT#NFT045606P| EXPLANTED| IMPLANTED| EXTENSION MODEL 7489 LOT#NHU068007V| IMPLANTED| EXPLANTED| IMPLANTED |