FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1852136
·
Received September 29, 2010
Report
- Report Number
- 3004209178-2010-07411
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- August 1, 2007
- Report Date
- August 31, 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
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PT EXPERIENCED A SURGING SENSATION. IN ADDITION, THE PT HAS BEEN ABLE TO FLIP THE DEVICE SINCE IT WAS IMPLANTED. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
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 | 59 YR | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD052447N| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA030345N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB005251N| EXPLANTED: |