RESTORE PRIME ADVANCED
Report
- Report Number
- 3004209178-2010-06802
- Event Type
- Malfunction
- Date Received
- September 3, 2010
- Date of Event
- January 1, 2010
- Report Date
- August 11, 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
(B)(4).
A PATIENT INITIALLY EXPERIENCED A BURNING SENSATION IN THEIR FEET WHEN THEIR DEVICE WAS TURNED ON. THE PATIENT WAS NOT RECEIVING THERAPEUTIC EFFECT IN REGARDS TO HER BACK. A REPROGRAMMING SEASON WAS SCHEDULED. LATER ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT HAD FELL TWO WEEKS AGO, AND WAS EXPERIENCING SEVER PAIN ON HER RIGHT SIDE. IT WAS NOTED THAT SHE HAD HER DEVICE IMPLANTED IN REGARDS TO PAIN ON HER LEFT SIDE, AND DID NOT HAVE PAIN ON HER RIGHT SIDE BEFORE IMPLANT. THE PATIENT COULD FEEL AND PHYSICALLY MOVE HER LEAD. THE LEAD SEEMED LIKE IT COULD BE MOVED 2 INCHES, AND WITH THE DEVICE SET TO 10 VOLTS, SHE WAS NOT ABLE TO FEEL STIMULATION. REPROGRAMMING THE DEVICE WAS ATTEMPTED SEVERAL TIMES, HOWEVER THE ISSUE REMAINED UNRESOLVED. AN X-RAY WAS CONDUCTED ON (B)(6) 2010, AND THE PATIENT NOTED THAT THE LEAD LOOKED LIKE IT WAS COILED UP IN HER SCAPULA AREA. INCREASED BASELINE PAIN WAS FELT IN THE LOCATION OF THE LEAD. A CONSULTATION WITH HER PHYSICIAN WAS SCHEDULED. THE PATIENT'S DEATH OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION 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 PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | PROGRAMMER: MODEL 37743, LOT# NKE148382N| LEAD: MODEL 39565-65, LOT# V448855032| IMPLANTED: |