FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2030445
·
Received March 9, 2011
Report
- Report Number
- 3004209178-2011-01797
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Report Date
- February 23, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT TOOK A FALL AND SUBSEQUENTLY EXPERIENCED STIMULATION IN THE WRONG LOCATION. SHE WAS SEEKING HELP WITH REPROGRAMMING. NO OTHER DETAILS WERE PROVIDED. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
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 | PROGRAMMER: MODEL 37743, LOT# NKE157374N| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V506482033| EXPLANTED:| LEAD: MODEL 3778, LOT# V506482034| ACCESSORY: MODEL 37752, LOT# NKA146603N| STIM ACCESSORY: MODEL 3550-39, LOT# N270212| EXPLANTED: |