FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1823436
·
Received August 25, 2010
Report
- Report Number
- 3004209178-2010-06448
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 27, 2010
- Report Date
- July 27, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT WAS HAVING ISSUES RECHARGING. PT WAS IN OVERDISCHARGE MODE FOR PAST SIX MONTHS TO ONE YEAR. A POWER ON RESET WAS DONE BUT PT SAID HE FELT LIKE HE WAS HAVING TO LEAVE CHARGER ON FOR SEVERAL DAYS TO GET ADEQUATE STIMULATION AND FULLY CHARGED. PT GOT FRUSTRATED AND QUIT USING HIS IMPLANTED SYSTEM. PT WAS UNABLE TO TELL IF HE WAS GETTING GOOD COUPLING WITH RECHARGING. REPLACED BATTERY AND IMPEDANCES WERE LESS THAN 2000 OHMS. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT # NKC009858N| IMPLANTED:| LEAD: MODEL 3999, LOT # V036846| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT # NJD054838N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT # NKC009857N| IMPLANTED: |