BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6985432 · Received October 27, 2017

    Report

    Report Number
    3004209178-2017-22710
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Report Date
    October 27, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THE CODES OF PATIENT CODES, DEVICE CODES AND EVALUATION CODE-CONCLUSION APPLIES TO LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-33, LOT# V071011, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT LEAD WAS REMOVED BY SOMEONE ELSE AND BROKE THE LEAD IN THE PROCESS. CALLER DID NOT KNOW WHEN. THEY TRIED TO REMOVE THE REST OF THE LEAD (B)(6) AND THE INTERNAL WIRES CAME OUT BUT THE COVERING WITH THE ELECTRODES STAYED IN. THERE WERE NO COMPLICATIONS OR THAT NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS IMPLANTED FOR URINARY DYSFUNCTIONAL/SACRAL NERVE STIMULATION AND OTHER INTERSTIM THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764474 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1