BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2190955 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-05549
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER-ON-RESET (POR) CONDITION OCCURRED FOLLOWING EXPOSURE TO SECURITY GATES AT AN AIRPORT. IMPEDANCES >4,000 OHMS WERE ALSO REPORTED ON ALL BIPOLAR PAIRS. AFTER INCREASING TEST VALUES, IMPEDANCES ON ALL UNIPOLAR PAIRS SHOWED >4,000 OHMS. AT 3.0 V AND 450 PW SOME PAIRS SHOWED IMPEDANCES WITHIN NORMAL LIMITS. THE NEUROSTIMULATOR BATTERY WAS LOW AND NEAR END OF LIFE. THE DEVICE WAS REPROGRAMMED TO C+, 1- AND THE PT WAS FEELING STIMULATION IN THE CORRECT AREA WITH THE NEW CONFIGURATION. THE PT ALSO EXPERIENCED POCKET STIMULATION WITH CERTAIN CONFIGURATIONS. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037 LOT# NJD080686N| LEAD: MODEL 3093 LOT# V192501