FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1900517
·
Received October 28, 2010
Report
- Report Number
- 6000032-2010-08565
- Event Type
- Malfunction
- Date Received
- October 28, 2010
- Report Date
- September 30, 2010
- Manufacturer
- MDT PUERTO RICO OPEATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS IN A POWER ON RESET (POR) CONDITION. THE PATIENT HAD DIFFICULTY RECEIVING ADEQUATE STIMULATION "FOR QUITE A WHILE." IT WAS NOT CLEAR, HOWEVER, WHETHER THIS DIFFICULTY WAS CAUSED BY THE PATIENT PROGRAMMER OR THE INS. THE BATTERY VOLTAGE WAS STATED TO BE GREATER THAN 3.9 VOLTS (WHILE THE DEVICE WAS TURNED OFF IN POR CONDITION). IT WAS ALSO STATED THAT THE DEVICE WAS NEAR THE END OF LIFE. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPEATIONS CO, MED REL | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PROGRAMMER: MODEL 7435, LOT# NFT033977P| EXPLANTED:| UNK CONVERSION TYPE: MODEL 3550-09,| IMPLANTED:| EXPLANTED:| LOT# LB6265| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3892, LOT# J0340308V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU028192V| EXPLANTED: |