FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1181393
·
Received September 24, 2008
Report
- Report Number
- 3004209178-2008-06113
- Event Type
- Malfunction
- Date Received
- September 24, 2008
- Date of Event
- August 29, 2008
- Report Date
- August 29, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FOR CHANGE IN DEVICE OUTPUT NOT OTHERWISE SPECIFIED.
Description of Event or Problem · 1
THE PT NOTICED A CHANGE IN OUTPUT FROM THE IMPLANTABLE NEUROSTIMULATOR AND THEN WAS UNABLE TO TURN ON HER DEVICE ON. A POWER ON RESET CONDITION AND LOSS OF TELEMETRY WAS CONFIRMED USING THE PHYSICIAN PROGRAMMER. BATTERY END OF SERVICE WAS SUSPECTED. ADDITIONAL INFO HAS BEEN REQUESTED. 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 | 36 YR | EXPLANTED:| LEAD: MODEL 3487A| EXPLANTED:| PROGRAMMER: MODEL 7435| IMPLANTED:| LEAD: MODEL 3587A| EXTENSION: MODEL 7495-51| EXPLANTED: |