FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1885241
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08377
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 1, 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). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED, THE PT'S LEADS WERE "STARTING TO BE EXPOSED THROUGH HER SKIN". THE PT'S HEALTH CARE PROVIDER (HCP) DECIDED TO EXPLANT THE LEADS AND EXTENSIONS, BUT LEFT THE IMPLANTABLE NEUROSTIMULATOR IN. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
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 | 51 YR | Required Intervention | IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V445509017| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA133026N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB060262V| EXTENSION: MODEL 37081, LOT# NJB074040V| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE145012N| LEAD: MODEL 3778, LOT# V445509018| EXPLANTED: |