FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1203509
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06618
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- July 1, 2008
- Report Date
- September 19, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. TRIPLE BEEPS WERE NOTED WHEN INCREASING AND DECREASING STIMULATION. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT WITH NO STIMULATION SENSATION. THE PATIENT PROGRAMMER WAS REPLACED, BUT THE SAME PROBLEMS CONTINUED TO OCCUR. THE PATIENT WAS REFERRED FOR STIMULATOR REPLACEMENT. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 70 YR | EXTENSION: MODEL 7495LZ| EXTENSION: MODEL 7495LZ| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435| LEAD: MODEL 3998 |