FDA Adverse Event
Malfunction
Summary report: N
SYNERGY COMPACT PLUS
MDR report key: 2061849
·
Received April 4, 2011
Report
- Report Number
- 3004209178-2011-02524
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- November 1, 2010
- Report Date
- March 3, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION IS TURNED OFF, THE PATIENT STILL FEELS STIMULATION IN HIS RIGHT LEG. THIS HAD BEEN GOING ON FOR ABOUT 2 MONTHS, AND THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. A COUPLE MONTHS LATER THE PROGRAMMER WAS DISPLAYING THE "CALL YOUR DOCTOR" ICON, AND THERE WAS A POWER ON RESET CONDITION. THE PATIENT COULD NOT ADJUST THE STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY COMPACT PLUS | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7479B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | EXPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# V004003| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU119255V| PROGRAMMER: MODEL 7439, LOT# NJD016999N| EXTENSION: MODEL 7489, LOT# NHU119256V| IMPLANTED:| IMPLANTED: |