FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1941207
·
Received December 22, 2010
Report
- Report Number
- 3004209178-2010-10683
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 8, 2010
- Report Date
- December 9, 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
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE STIMULATION STARTED TO WORK DIFFERENTLY AND WAS NOT CONTROLLING THE PT'S PAIN. THE PT WAS UNABLE TO ADJUST THE STIMULATION; THE PT WAS VISION IMPAIRED AND COULD NOT READ THE SCREEN. 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 PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | LEAD: MODEL 3778, LOT# V572265015| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE156706N| EXPLANTED:| LEAD: MODEL 3778, LOT# V572265016| IMPLANTED: |