FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1872218
·
Received October 14, 2010
Report
- Report Number
- 3004209178-2010-07961
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Report Date
- September 16, 2010
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PT HAD LOST STIMULATION SENSATION. IMPEDANCE MEASUREMENTS OF ELECTRODE CONTACT 8-15 SHOWED >3600 OHMS. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT 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 | LEAD: MODEL 3487A, LOT# V088421| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB003841N| EXPLANTED:| LEAD: MODEL 3776, LOT # V252017002| STIM ACCESSORY: MODEL 37092, LOT# 240310001N| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA135011N| PROGRAMMER: MODEL 37743, LOT# NKE143097N| IMPLANTED:| EXPLANTED: |