BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2904935 · Received January 9, 2013

    Report

    Report Number
    3007566237-2013-00095
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093BLUE_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A LEAD WAS DAMAGED PRIOR TO THE PROCEDURE. IT WAS INDICATED THIS WAS A STAGE 2 PROCEDURE. IT WAS NOTED WHEN THE LEAD WAS REMOVED FROM THE PERCUTANEOUS EXTENSION, THE INSULATION ON THE LEAD "APPEARED TO BE PULLED BACK." THE HEALTHCARE PROVIDER (HCP) DECIDED TO CONNECT THE IMPLANTABLE NEUROSTIMULATOR AND USED A SILK TIE TO SECURE THE INSULATION ON THE LEAD. IT WAS INDICATED THAT IMPEDANCES WERE "WITHIN NORMAL RANGES." THE HCP DECIDED TO PROCEED WITH AND FINISH THE PROCEDURE. IT WAS FURTHER STATED THE PATIENT WAS GETTING A "GOOD MOTOR RESPONSE." NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12436 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1