FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2030404
·
Received March 9, 2011
Report
- Report Number
- 3004209178-2011-01766
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 6, 2011
- Report Date
- February 7, 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 LOSS OF THERAPEUTIC EFFECT AND STIMULATION FELT FAINTER THAN USUAL. SHE HAS PAIN IN HER POCKET. SHE HIT THE INS ON THE COUCH YESTERDAY AND HAS BEEN IN A LOT OF PAIN SINCE. IT WAS NOTED THAT SHE WAS TRAVELING. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | EXPLANTED:| IMPLANTED:| LEAD: MODEL 39286-65, LOT# V406507018| PROGRAMMER: MODEL 37743, LOT# NKE144277N| ACCESSORY: MODEL 37752, LOT# NKA138203N |