FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1935958
·
Received December 3, 2010
Report
- Report Number
- 3004209178-2010-10187
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 20, 2010
- Report Date
- November 23, 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
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, STIMULATION IN THE WRONG LOCATION AND NO STIMULATION. SHE FELT MORE PAIN AND A SHOCKING/JOLTING SENSATION WHEN HER NEUROSTIMULATOR (INS) WAS TURNED ON. THE PAIN ALSO FELT AS NUMBING AND HER VEINS PUFFED UP WHEN THE INS WAS TURNED ON. ON (B)(6) 2010 SHE COULD NOT FEEL HER LEG AND IT CAUSED HER TO FALL. SHE HAS PAIN DOWN HER LEG AND AROUND THE DEVICE. THE INS STOPPED WORKING FOR HER LEFT LEG. HER SYMPTOMS STARTED FOLLOWING THE FALL. SHE WAS AT HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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 | 51 YR | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V461164002| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE145481N| LEAD: MODEL 3778, LOT# V461164001| IMPLANTED: |