BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3041139 · Received April 8, 2013

    Report

    Report Number
    3007566237-2013-01155
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN "END OF SERVICE" (EOS) MESSAGE WAS SEEN BY THE HEALTH CARE PROFESSIONAL (HCP). IT WAS NOTED THAT THE HCP "THOUGHT THE DEPLETION WAS PREMATURE." IT WAS NOTED THAT THE PATIENT HAD BEEN IMPLANTED WITH THE DEVICE FOR ABOUT A YEAR AND HALF AS OF THE DATE OF THIS REPORT. IT WAS NOTED THAT THE AMPLITUDE WAS 8.4 VOLTS AND THE PATIENT HAD OTHER PROGRAMS AT 8.0 AND 6.5 VOLTS. IT WAS NOTED THAT THE "CYCLING WAS ENABLED WITH 50 SECONDS ON AND 10 SECONDS OFF." IT WAS NOTED THAT THE LONGEVITY WAS ESTIMATED TO BE 2.2 YEARS. WITHOUT CYCLING, THE LONGEVITY ESTIMATE WAS 8 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143079 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1