FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2053478
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01506
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Report Date
- February 12, 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT THE STIMULATION DID NOT "FEEL HIGH ENOUGH IN BACK" AND WAS NOT REACHING PAIN YET. SHE MET A MEDTRONIC REP IN THE PAST. SHE NEEDED HELP WITH REPROGRAMMING. THE HEALTH CARE PROVIDER CONFIRMED THAT SHE WAS SEEN ON (B)(6) 2010 AND STILL HAD NEED FOR REPROGRAMMING. SHE WAS LAST SEEN IN (B)(6) 2010 AND HAS NOT BEEN SEEN SINCE. SHE WAS CHARGING MORE THAN EXPECTED. WHILE STIMULATION WAS TURNED ON SHE EXPERIENCED NO STIMULATION SENSATION. THE STIMULATION WAS ON AND SHE COULD NOT TURN IT OFF, THEN IT TURNED OFF WITHOUT HER MAKING ANY ADJUSTMENTS.
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 | PROGRAMMER: MODEL 37743, LOT# NKE144463N| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V424242038| ACCESSORY: MODEL 37752, LOT# NKA138746N| EXPLANTED: |