BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1071288 · Received July 8, 2008

    Report

    Report Number
    3004209178-2008-03819
    Event Type
    Injury
    Date Received
    July 8, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTABLE NEUROSTIMULATOR (INS) HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED FUNCTIONING. THE IMPLANTABLE NEUROSTIMULATOR WAS REMOVED AND RETURNED TO THE MFR. A LEAD ISSUE WAS QUESTIONED, BUT THE LEADS WERE NOT RETURNED AS THEY FRACTURED WHEN REMOVING. THERE WAS NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESSORY MODEL 37752 LOT# NKA027678N| LEAD MODEL 3778-45 LOT# V024012007| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT# NJB003046V| PROGRAMMER MODEL 37742 LOT# NJD042934N| IMPLANTED| LEAD MODEL 3887-33 LOT# V008628| IMPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC010721N| IMPLANTED