FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2244034
·
Received August 24, 2011
Report
- Report Number
- 3004209178-2011-06779
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- June 1, 2011
- Report Date
- August 1, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT WAS EXPERIENCING A WARMTH/HEAT SENSATION AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE WHEN THE INS WAS TURNED OFF. IT WAS NOTED THAT THE DEVICE HAD NOT BEEN USED FOR THE PAST 6 MONTHS. THE HEALTH CARE PROVIDER (HCP) CONFIRMED THE TEMPERATURE DIFFERENCE ON THE SKIN LOCATED NEAR THE BATTERY AND ATTRIBUTED THE EVENT TO THE DEVICE EMITTING HEAT. THE HCP INDICATED THAT THE INS WILL BE EXPLANTED. NO PT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | PROGRAMMER: MODEL 37743, LOT # NKE155593N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT # V575598016| ACCESSORY: MODEL 37752, LOT # NKA146384N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT # V575598015 |