FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2260012
·
Received August 31, 2011
Report
- Report Number
- 3004209178-2011-07141
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Report Date
- August 17, 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
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION OCCURRED. THE PT SOUGHT A HEALTHCARE PROVIDER WHO COULD EVALUATE THE DEVICE. 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 | LEAD: MODEL 39565-30, LOT # N150774001| ACCESSORY: MODEL 37752, LOT # NKA112392N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB034292V| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB034291V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE150014N |