BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-PASS ACE

    MDR report key: 1896514 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04799
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 17, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    K861481
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IN 2007, -LEAD LEAKING- WAS OBSERVED. THE SYSTEM WAS PROGRAMMED OFF BUT LEFT IMPLANTED DUE TO APPROPRIATE INTRINSIC PACING. ON (B)(6) 2010, IT WAS OBSERVED THAT THE LEAD WAS -BEING CUT AT 1 CM FROM THE TIP IN THE ATRIUM-. THE TIP REMAINED IN THE RIGHT AURICLE AND THE PROXIMAL PORTION WAS JUMPING UP TO THE SUPERIOR VENA CAVA. VIA X-RAY, THE COIL DID NOT APPEAR EXPOSED AND THROMBOSIS WAS OBSERVED. THE LEAD WAS LEFT IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-PASS ACE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1012T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention