FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1872535
·
Received October 12, 2010
Report
- Report Number
- 3004209178-2010-07842
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 14, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A WARNING, POWER-ON-RESET (POR) CONDITION. ADD'L INFO 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 ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | EXTENSION: MODEL 37081, LOT#: NJB044411V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT#: NKA030934N| PROGRAMMER: MODEL 37742, LOT#: NJD047634N| EXPLANTED:| EXTENSION: MODEL 37081, LOT#: NJB044410V| LEAD: MODEL 39565-30, LOT#: N171076002| IMPLANTED: |