FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2061791
·
Received March 30, 2011
Report
- Report Number
- 3004209178-2011-02410
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Report Date
- March 14, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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 ORIGINALLY REPORTED THAT THE INS MAY BE FLIPPED. IT WAS LATER REPORTED THAT THE INS HAD BECOME OVER-DISCHARGED AND COULD NOT GET IT TO START BACK UP AFTER MANY HOURS OF TRYING. X-RAY CONFIRMED THAT THE DEVICE WAS NOT FLIPPED. THE INS WAS GOING TO BE REPLACED WITH A NON-MEDTRONIC DEVICE.
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 | EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB040261V| LEAD: MODEL 3777, LOT# V148442013| EXPLANTED:| LEAD: MODEL 3777, LOT# V148442012| EXTENSION: MODEL 37081, LOT# NJB039300V| PROGRAMMER: MODEL 37743, LOT# NKE116855N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT#NKA118507N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: |