BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2964694 · Received February 15, 2013

    Report

    Report Number
    3007566237-2013-00508
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 14, 2012
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS OF THE STYLET REVEALED THE FOLLOWING: THE STYLET HANDLE BROKE JUST INSIDE THE PACKAGING TUBE. THE DIAMETER OF THE STYLET HANDLE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE INNER DIAMETER AND THICKNESS OF THE PACKAGING TUBE WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A KNOWN GOOD LEAD AND STYLET WERE ABLE TO BE INSERTED AND WITHDRAWN FROM THE PACKAGING TUBE WITHOUT DIFFICULTY. THE FACT THAT THE PRODUCT IS WITHIN SPECIFICATIONS SUGGESTS THAT THIS WAS A HANDLING ISSUE. FINAL DEVICE ANALYSIS OF THE SCREENER CABLE REVEALED THE FOLLOWING: NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE WHITE TIP OF THE TEST LEAD WAS BROKEN AT THE STYLET INSIDE THE PLASTIC SHEATH." THE EVENT OCCURRED DURING THE PROCEDURE AND THE STYLET WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68617 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3057-1SC N320635

    Patients

    Seq Age Sex Outcome Treatment
    1