BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3923569 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12742
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 16, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3058 (LOT # NJY230850H ) SHOWED INS FUNCTIONALLY OKAY, INSIGNIFICANT ANOMALIES. NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS : PRODUCT ID: 3889-33, LOT# VA0AT7V, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-33, LOT# VA0AT7V, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD NORMAL ERI (ELECTIVE REPLACEMENT INDICATOR). THE PATIENT REPORTED SHOCKING SENSATION ON SETTING WHEN 0 ELECTRODE WAS ACTIVE. THEY REVISED LEAD AND WHEN VIEWING GENERATOR IN POCKET SURGEON NOTICED FLUID IN HEADER OF DEVICE. ALL IMPEDANCE WAS WITHIN NORMAL RANGE BUT PHYSICIAN MADE DECISION TO REPLACE GENERATOR TO PROVIDE A SAFE AND EFFECTIVE LONG TERM THERAPY OUTCOME A NEW DEVICE WAS IMPLANTED ON (B)(6) 2014 . ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS DOING FINE WITH NEW REPLACEMENT BATTERY. ADDITIONAL INFORMATION RECEIVED: NORMAL BATTERY DEPLETION WAS NOTED AS NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400366 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention