FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1993764
·
Received January 13, 2011
Report
- Report Number
- 3004209178-2011-00341
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- December 30, 2010
- Report Date
- January 3, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION AND PAIN IN THE BACK AREA. THE PT WENT TO THE EMERGENCY ROOM ON SATURDAY NIGHT WHERE HE WAS DIAGNOSED WITH MUSCLE SPASMS. THE PT ALSO HAD AN INFECTION 2 WEEKS AGO AND WAS PUT ON ANTIBIOTICS. ADD'L INFO WAS 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 | 49 YR | IMPLANTED:| LEAD: MODEL 39565-65, LOT# V570963016| STIM ACCESSORY: MODEL 37092, LOT# 252640001| PROGRAMMER: MODEL 37743, LOT# NKE157185N| EXPLANTED: |