BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-PASS ACE

    MDR report key: 2905217 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00458
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 17, 2012
    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

    IT WAS REPORTED THAT DURING THE PULSE GENERATOR REPLACEMENT, IT WAS NOTED THAT THE LEAD INSULATION WAS DAMAGED. LEAD IMPEDANCE OF LESS THAN 200 OHMS WAS NOTED BEFORE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10755 FAST-PASS ACE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1012T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention