FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1968684
·
Received December 30, 2010
Report
- Report Number
- 3004209178-2010-10874
- Event Type
- Malfunction
- Date Received
- December 30, 2010
- Date of Event
- September 1, 2010
- Report Date
- December 16, 2010
- 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD NOT RECHARGED SINCE (B)(6) 2010 AT WHICH TIME THE COMPANY REP TURNED THE STIMULATION DOWN TO 0 VOLTS THEN OFF. THE PT WAS NOW RECHARGING, WITH 8 COUPLING BARS SEEN, BUT WAS GETTING A POWER-ON-RESET (POR) MESSAGE SCREEN ON THEIR PROGRAMMER. THE COMPANY REP REVIEWED THE PROCEDURE FOR CLEARING THE POR WITH THE PT PROGRAMMER WITH THE PT BEFORE PROCEEDING WITH FURTHER RECHARGING. IT WAS NOTED THAT THE PT WAS GOING TO HAVE A LEAD REVISION ON (B)(6) 2011. ADDITIONAL INFO WAS REQUESTED. SEE MFRS REPORT # 3004209178201010875.
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 | 47 YR | EXPLANTED:| LEAD: MODEL 39286-65, LOT# N212239003| ACCESSORY: MODEL 37752, LOT# NKA142466N| PROGRAMMER: MODEL 37743, LOT# NKE152101N| IMPLANTED: |