FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1885272
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08428
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- April 1, 2010
- Report Date
- April 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED A SENSATION OF OVERSTIMULATION FROM THEIR DEVICE. IT WAS STATED THE PT HAD A FIVE WEEK STAY IN THE HOSPITAL FOR AN UNRELATED PROCEDURE, AND THE FIRST TIME HE USED HIS DEVICE AFTER DISCHARGE, THE DEVICE CAPTURED THE PAIN, BUT WAS OVERSTIMULATING. IT WAS ALSO STATED THE PT HAD LOST 100 POUNDS SINCE HIS DEVICE WAS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | LEAD: MODEL 3776, LOT# V097141029| LEAD: MODEL 3776, LOT# V097141028| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA036918N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE100676N| EXPLANTED: |