BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3833810 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09669
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    December 1, 2013
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-33, LOT # V887374, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER REPORTS TELEMETRY ISSUES. THE CALLER WAS WITH THE PATIENT AND TRYING TO INTERROGATE STIMULATOR WITH CLINICIAN PROGRAMMER AND GETTING TELEMETRY FAILURE MESSAGE. CALLER ALSO STATES THEY CANNOT INTERROGATE STIMULATOR USING PATIENT PROGRAMMER. CALLER STATES THEY ARE IN ROOM WHERE THEY TYPICALLY INTERROGATE DEVICES AND WERE NOT NEAR EMI (ELECTROMAGNETIC INTERFERENCE). THE CALLER TRIED TO USE PATIENT PROGRAMMER WITH AND WITHOUT THE ANTENNA AND CALLER COULD NOT GET TELEMETRY. THE CALLER WAS OFFERED TO RUN LONGEVITY CALCULATION AND CALLER STATES THEY DO NOT HAVE PATIENT SETTINGS AS PATIENT HASN'T BEEN SEEN FOR INTERSTIM SINCE (B)(6) 2012. THE PATIENT TOLD CALLER IT HAS BEEN AWHILE SINCE THEY FELT STIMULATION. ASKED FOR EVENT DATE AND CALLER STATES IT SOUNDS LIKE IT HAS BEEN "SEVERAL MONTHS" BUT THE PATIENT WAS NOT A GOOD HISTORIAN. THE PATIENT REPORTS RETURN OF SYMPTOMS (URGENCY, FREQUENCY, AND LEAKAGE). THE PATIENT STATES SYMPTOM RETURN STARTED AFTER THERE LAST APPOINTMENT AT THE CLINIC IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310609 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR