BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1171403 · Received September 17, 2008

    Report

    Report Number
    3004209178-2008-05853
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IMPEDANCE READINGS>10,000 OHMS WAS REPORTED. THE SPECIFIC VALUES WERE NOT PROVIDED. ONLY ONE SIDE OF THE LEAD APPEARED OUT OF RANGE, HOWEVER, THE OTHER PART OF THE LEAD HAD A FEW OUT OF RANGE AS WELL. A PROBLEM WITH THE NEUROSTIMULATOR WAS ALSO REPORTED. THE END OF SERVICE (EOS) / END OF LIFE (EOL) MESSAGE WAS DISPLAYED. IT WAS RECOMMENDED THE NEUROSTIMULATOR BE REPLACED. THE MANUFACTURER REP INQUIRED IF THE IMPEDANCE RESULTS COULD BE INFLUENCED BY THE DEPLETED NEUROSTIMULATOR. IT WAS RECOMMENDED IMPEDANCES BE TESTED INTRA-OPERATIVELY, AND THE LEAD IMPEDANCE BE CHECKED SEPARATELY.

    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 56 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778| EXPLANTED:| PROGRAMMER: MODEL 37742| IMPLANTED:| EXTENSION: MODEL 37081