BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 1991297 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02335
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT'S MONITOR TRANSMISSION SHOWED A LEAD WARNING. SINCE THE DEVICE IS PROGRAMMED AIR, THE ATRIAL LEAD WAS SUSPECTED. UPON INVESTIGATION FOUND THAT THE RIGHT VENTRICULAR LEAD HAS A KNOWN INSULATION BREAK AND IS NOT PROGRAMMED FOR USE, BUT REMAINS IMPLANTED. THE LEAD WARNING WILL BE CLEARED AT NEXT VISIT. IT WAS ALSO REPORTED THAT THE LEAD WARNING HAD NOT BEEN CLEARED, AND UPON INTERROGATION NOTED THAT THERE WAS LOW IMPEDANCE AND THE INSULATION FAILURE ON THE VENTRICULAR LEAD. THE LEAD REMAINS IMPLANTED BUT NOT PROGRAMMED FOR USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S MONITOR TRANSMISSION SHOWED A LEAD WARNING. SINCE THE DEVICE IS PROGRAMMED AAIR, THE ATRIAL LEAD WAS SUSPECTED. UPON INVESTIGATION FOUND THAT THE RIGHT VENTRICULAR LEAD HAS A KNOWN INSULATION BREAK AND IS NOT PROGRAMMED FOR USE, BUT REMAINS IMPLANTED. THE LEAD WARNING WILL BE CLEARED AT NEXT VISIT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other E2DR01 IMPLANTABLE PULSE GENERATOR| 5524M IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD| E2DR01 IMPLANTABLE PULSE GENERATOR