BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1953815 · Received January 4, 2011

    Report

    Report Number
    3004209178-2011-00001
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    September 20, 2010
    Report Date
    December 17, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED HEATING AROUND THE NEUROSTIMULATOR (INS) DURING AN MRI OF HIS STOMACH AND HAD IT REPLACED. IT FELT HOT AROUND THE INS AND LEAD LOCATION. THE INS WAS ON PRIOR TO THE MRI. THE INS WAS LOCATED IN THE BUTTOCK. IT WAS NOTED THAT HE HAD A KNEE REPLACEMENT AND EXPERIENCED HEATING AROUND HIS KNEES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EXPLANTED:| LEAD: MODEL 3778, LOT# V012472| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB005392V| IMPLANTED:| LEAD: MODEL 3778, LOT# V011950| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA015651N| PROGRAMMER: MODEL 37742, LOT# NJD032764N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB007413V| IMPLANTED:| EXPLANTED: