FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1980281
·
Received February 2, 2011
Report
- Report Number
- 3004209178-2011-00801
- Event Type
- Injury
- Date Received
- February 2, 2011
- Date of Event
- December 27, 2010
- Report Date
- December 6, 2016
- 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
- NY, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE NEUROSTIMULATOR WAS RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
THE PATIENT CHOSE NOT TO RECHARGE THE IMPLANTABLE NEUROSTIMULATOR. THE DEVICE BECAME DEEPLY DISCHARGED. IT WAS REPLACED. THE PATIENT EXPERIENCED NO SIGNS OR SYMPTOMS ASSOCIATED WITH THE EVENT. THE PATIENT RECOVERED WITHOUT SEQUELA AFTER REPLACEMENT.
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 | 47 YR | Female | Required Intervention | EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB020073V| EXTENSION: MODEL 37081, LOT# NJB020074V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N124465003| PROGRAMMER: MODEL 37743, LOT# NKE160336N| RECHARGER: MODEL 37752, LOT# KNA033510N| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB020074V| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB020073V| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N124465003| RECHARGER: MODEL 37752, LOT# KNA033510N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE160336N| IMPLANTED:| EXPLANTED: |