BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3313818 · Received August 28, 2013

    Report

    Report Number
    3004209178-2013-15326
    Event Type
    Malfunction
    Date Received
    August 28, 2013
    Report Date
    August 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V800432, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT HAD TELEMETRY ISSUES. IT WAS STATED THE PATIENT¿S IMPLANT WAS 4 CM DEEP AND WAS EASILY PALPABLE BY TOUCH. IT WAS NOTED TELEMETRY WITH BOTH THE CLINICIAN PROGRAMMER AND PATIENT PROGRAMMER WAS NOT POSSIBLE AT TIME OF REPORT. REPORTEDLY, THE PATIENT WASN'T FEELING STIMULATION AND HADN'T SINCE (B)(6) 2013. IT WAS STATED THE LONGEVITY ESTIMATE WAS AT ABOUT 9 MONTHS AND THE PATIENT HAD THE IMPLANT FOR TWO YEARS. IT WAS REVIEWED THAT THE IMPLANT WAS A DEPLETED BATTERY.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT HAD NO CONCERNS WITH THEIR DEVICE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. DISPLAY SHOWED "CALL YOUR DOCTOR" ICON. THERE WAS A POR CONDITION. IT WAS NOTED THAT: "IT IS ONE WITH A TRIANGLE THAT PATIENT SERVICES CAN NOT CLEAR". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422836 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR