BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2191722 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05700
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR NORMAL BATTERY DEPLETION, IMPEDANCE READINGS WERE >4000 OHMS ON THE 0 AND 2 ELECTRODES. THE LEAD AND EXTENSION HAD NOT BEEN REPLACED DURING THE SURGERY. IT WAS LATER REPORTED THAT THE LEAD WAS NOT PROVIDING ADEQUATE STIMULATION AND THAT ONLY TWO OF THE FOUR CONTACTS STILL WERE "WORKING.'' A LEAD REVISION WAS DISCUSSED BUT HAD NOT YET BEEN SCHEDULED AT THE TIME OF THIS REPORT. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT WHEN ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-66, LOT # XS0001827N| IMPLANTED:| LEAD: MODEL 3487A, LOT # N21861| EXPLANTED: