FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1926094
·
Received November 10, 2010
Report
- Report Number
- 3004209178-2010-09190
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 21, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS "RUINED" AFTER THE PT STOOD TOO CLOSE TO A MICROWAVE OVEN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA133431N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB042720V| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE111078N| IMPLANTED:| LEAD: MODEL 3777, LOT# V170807003| IMPLANTED: |