BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1181390 · Received September 24, 2008

    Report

    Report Number
    3004209178-2008-06101
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR WOULD TURN OFF IN THE MIDDLE OF THE NIGHT AND AT TIMES DURING THE DAY. THE DEVICE WAS PROGRAMMED TO DELIVER STIMULATION 24 HOURS A DAY VIA TWO PROGRAMMING GROUPS. THE PATIENT DID NOT ADJUST HER DEVICE PRIOR TO BEDTIME. A NEW PROGRAMMING GROUP WAS SET UP AND THE STIMULATOR WORKED WELL AFTERWARD. THE PATIENT'S PROGRAMMER DID NOT RESPOND EACH TIME THE PATIENT INITIATED CHANGES. THE PATIENT USED THE RECHARGER TO TURN ON THE IMPLANTABLE NEUROSTIMULATOR. THE BATTERY WAS REPLACED IN HER PROGRAMMER AND SHE WAS INSTRUCTED NOT TO USE HER RECHARGER TO TURN HER STIMULATION ON AND OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR EXTENSION: MODEL 37083| EXPALNTED:| EXPLANTED:| LEAD: MODEL 3887| EXPLANTED:| LEAD: MODEL 3887| EXPLANTED:| EXTENSION: MODEL 37083