BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6112912 · Received November 18, 2016

    Report

    Report Number
    3007566237-2016-04134
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A LOSS OR CHANGE OF THERAPY AS OF DATE NOTIFIED. STIMULATION WAS NOT FELT WITH THERAPY CONFIRMED TO BE ON. AMPLITUDE WAS THEN INCREASED FROM 2.1V TO 2.4V AND THE PATIENT FELT IT IN THE CORRECT AREA. FOLLOW UP WITH THE HEALTHCARE PROVIDER (HCP) IS TO BE CONDUCTED. THE PATIENT'S INDICATION FOR IMPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763717 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1