BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1180865 · Received September 23, 2008

    Report

    Report Number
    3004209178-2008-06063
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS DEPLETED APPROXIMATELY 3 MONTHS AFTER IMPLANT. THE LONGEVITY ESTIMATE WAS 24 MONTHS GIVEN THE FOLLOWING PARAMETERS. THE DEVICE WAS USED CONTINUOUSLY AND PROGRAMMED TO USE 1 POSITIVE AND 1 NEGATIVE ELECTRODE WITH A RATE OF 20 HERTZ, PULSE WIDTH OF 30 MICROSECONDS. THE AMPLITUDE VARIED FROM 3 VOLTS AT IMPLANT TO 6 VOLTS AND THEN 8.1 VOLTS FOR ABOUT A WEEK BEFORE THE BATTERY WAS DEPLETED. THERE WERE NO SHORT CIRCUITS. ALL BIPOLAR ELECTRODE IMPEDANCES INVOLVING CONTACT #5 WERE GREATER THAN 10,000 OHMS; THE HCP PROGRAMMED AROUND THIS ELECTRODE. THE DEVICE WAS EXPLANTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778| PROGRAMMER: MODEL 37742| LEAD: MODEL 3778| EXPLANTED: