FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2061877
·
Received April 5, 2011
Report
- Report Number
- 3004209178-2011-02589
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 8, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STIMULATION WAS INTERMITTENT FOR ABOUT A MONTH PRIOR TO THE REPORT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS ALSO NOTED THAT THE RECHARGER NOTED THE ANTENNA WAS TOO HOT. IT WAS NOTED THAT THE PATIENT HAD "LOST A TON OF WEIGHT" AND THE STIMULATOR WAS NOW DIRECTLY UNDER THE PATIENT'S BELT. THE PATIENT AND THE PHYSICIAN FELT THE WEIGHT LOSS WAS CAUSING HEATING DURING RECHARGE. FURTHER TROUBLESHOOTING WAS BEING CONSIDERED. 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 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | LEAD: MODEL 3778, LOT# V119687020| PROGRAMMER: MODEL 37743, LOT# NKE125122N| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA124284N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V207202025 |