BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 1990175 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01865
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH VOLTAGE ELECTRODE, A SUBCUTANEOUS (SQ) PATCH DESIGN WHICH WAS IMPLANTED EPICARDIALLY, HAS HIGH IMPEDANCE. IMPEDANCE STARTED TO CLIMB APPROXIMATELY ONE TO TWO YEARS AGO, WITH FLUCTUATIONS, AND HAS BEEN HIGH FOR THE PAST 14 MONTHS. IT WAS ALSO REPORTED THAT CHEST X-RAY CONFIRMED COMPLETE FRACTURE OF THE HIGH VOLTAGE ELECTRODE. IT WAS ALSO REPORTED THE LEFT VENTRICULAR LEAD IMPEDANCE HAS BEEN RISING WITH THE HIGH VOLTAGE IMPEDANCE, AND ALSO THAT THE LEFT VENTRICULAR THRESHOLD IS HIGH. THE HIGH VOLTAGE ELECTRODE HAS BEEN SCHEDULED FOR REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4058 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE LEAD ADAPTOR