FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2081329
·
Received April 21, 2011
Report
- Report Number
- 3004209178-2011-02981
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- April 3, 2011
- Report Date
- April 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO THE PT EXPERIENCED DIFFICULTY RECHARGING. PT SERVICES SUGGESTED THE MANUFACTURER'S REPRESENTATIVE TRY THE ANTENNA LOCATE FEATURE AS THE RECHARGER WAS FROZEN ON THE ANTENNA LOCATE SCREEN. THIS RESULTED IN A POWER ON RESET DISPLAYED ON THE RECHARGER SCREEN WHICH THEN LEAD TO A NORMAL RECHARGING SCREEN. PT WAS ABLE TO RECHARGE WITH 4 BARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | H0266810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB065031V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V326974022| LEAD: MODEL 3778, LOT# V358462007| PROGRAMMER: MODEL 37743, LOT# NKE140114N| RECHARGER: MODEL 37752, LOT# NKA135185N| EXTENSION: MODEL 37081, LOT# NJB064830V |