FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1983022
·
Received February 4, 2011
Report
- Report Number
- 3004209178-2011-00911
- Event Type
- Injury
- Date Received
- February 4, 2011
- Report Date
- January 20, 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT STARTING APPROXIMATELY IN (B)(6) 2008. THE DEVICE WAS REPROGRAMMED BY THE PATIENT'S HEALTHCARE PROVIDER. FOLLOWING REPROGRAMMING, THE STIMULATION WAS TOO STRONG. THE PROGRAMMER WAS REPLACED AND NO ISSUES WERE NOTED WITH RECHARGING; THE PATIENT COULD SUCCESSFULLY RECHARGE. IT WAS LATER STATED THAT THE PATIENT HAD SURGERY "THREE YEARS AGO" TO FIX THE PROBLEM WITH HER SYSTEM. THE DETAILS WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER: MODEL 37742, LOT# NJD039172N| EXPLANTED:| LEAD: MODEL 3487A, LOT# V020841| IMPLANTED:| LEAD: MODEL 3778, LOT# V022016024| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB006719N| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA029239N| LEAD: MODEL 3487A, LOT# V020841| EXPLANTED:| IMPLANTED: |