BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIENT

    MDR report key: 4883189 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-06412
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), ONLY ONE RIGHT ATRIAL (RA) SET SCREW HAD BEEN LOOSENED. THE PHYSICIAN ATTEMPTED TO REMOVE THIS RIGHT ATRIAL (RA) LEAD OUT OF THE DEVICE HEADER. THE INSULATION WAS PULLED APART AND THE CONDUCTOR COIL WAS UNWOUND WHILE PART OF THE TERMINAL PIN REMAINED IN THE DEVICE HEADER. THE SECOND SET SCREW WAS LOOSENED AND THE TERMINAL END WAS REMOVED FROM THE DEVICE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE WAS SUCCESSFULLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425549 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 1290| 4088| 4469| MISMATCH| G146| E030| 0185