BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 4132106 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15958
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 ROUTINE DEVICE REPLACEMENT, THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD AND REPLACEMENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE ON THE PACE/SENSE PORTION OF THE LEAD AND HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. SHOCK IMPEDANCE MEASUREMENTS DURING DEFIBRILLATION THRESHOLD (DFT) TESTING WERE OBSERVED TO BE 60-64 OHMS. THE PROGRAMMED CONFIGURATION WAS DISTAL COIL TO CAN. THE POCKET WAS CLOSED AND THE PATIENT WAS SCHEDULED FOR FOLLOW UP FOR A DATE IN THE FUTURE. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THE PHYSICIAN REQUESTED DISK ANALYSIS OF STORED EPISODES AND ELECTROGRAMS (EGMS) FROM THE PREVIOUS EXPLANTED DEVICE TO SEE IF NOISE WAS PRESENT PRIOR TO DEVICE REPLACEMENT. ANALYSIS OF THE MEMORY FROM THE PREVIOUS DEVICE REVEALED NO NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610649 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR T135| E141| T177| 0185