FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2082825
·
Received May 3, 2011
Report
- Report Number
- 3004209178-2011-03202
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- April 15, 2008
- Report Date
- April 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WERE COUPLING AND/OR COMMUNICATION ISSUES WHILE RECHARGING. IT WAS NOT CLEAR IF THE DEVICE WAS OVER-DISCHARGED, BUT THE REPORTER STATED PATIENT EDUCATION ISSUES WERE PRIMARY REASON FOR OVER-DISCHARGE. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention | IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA019553N| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD024859N| EXTENSION: MODEL 37083, LOT# NKC005533N |