FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1823482
·
Received August 25, 2010
Report
- Report Number
- 3004209178-2010-06420
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 28, 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
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE IMPLANTABLE NEUROSTIMULATOR LEAD WIRE ERODED THROUGH THE PATIENT'S SKIN. THE HCP PUSHED THE LEAD BACK UNDER THE SKIN AND SEWED THE AREA SHUT. THE PATIENT ALSO FELT SHOCKING IN HER LOWER BODY WHEN THE IMPLANTABLE NEUROSTIMULATOR BATTERY GOT LOW TO OVERDISCHARGED. THE PATIENT WAS IN JAIL AND WAS NOT ALLOWED ACCESS TO HER RECHARGER. SHE WAS EXPERIENCING THE SHOCKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V394607035| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE142535N| EXPLANTED:| LEAD: MODEL 3487A, LOT# V378167| IMPLANTED:| LEAD: MODEL 3888, LOT# V386604| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB004020V| EXPLANTED:| IMPLANTED: |