BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4198737 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20307
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 30, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V133358, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V133358, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BROKEN LEAD WIRES AND THE HCP (HEALTHCARE PROVIDER) WANTED TO REPAIR THE DEVICE BUT THE PATIENT WAS THINKING SHE WANTED IT REMOVED BECAUSE IT REALLY HADN'T HELPED HER. RIGHT WHEN IT WAS IMPLANTED IT WORKED FOR THE PATIENT. SHE HAD SOME NUMBING IN HER TOES AND COULD FEEL THE SHOCKS. AROUND (B)(6) 2012 THE PATIENT DIDN'T FEEL ANYTHING. SHE WENT TO THE DOCTOR IN (B)(6) 2014 AND IT WAS DETERMINED THAT THE LEADS WERE BROKEN. THE REMOVAL WAS SET FOR MONDAY. IT WAS NOTED THAT THE PATIENT COULD NOT TAKE ORAL MEDICATIONS BECAUSE THEY DRY HER MOUTH OUT. THE HEALTHCARE PROVIDER NOTED THAT THE PATIENT REQUESTED REMOVAL OF INTERSTIM HARDWARE AS THE PATIENT SAID "PROBLEM RESOLVED" AND THE PATIENT LACKED INSURANCE COVERAGE FOR FUTURE BATTERY REPLACEMENTS. THE PATIENT WAS TO HAVE THE DEVICE REMOVED AT ANOTHER LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678510 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention