BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3212422 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08555
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION NOTED A HOLE IN THE LEFT VENTRICULAR SEAL PLUG. X-RAY INSPECTION NOTED THE PLASMA FUSE WAS BLOWN. THE BATTERY STATUS WAS END OF LIFE (EOL). IT WAS NOTED THE EOL STATUS WAS SET BY A 45 SECOND CHARGE TIME. THE CAUSE OF THE 45 SECOND CHARGE TIME AND THE EOL BATTERY STATUS WAS ELECTRICAL OVERSTRESS DAMAGE DUE TO THE DEVICE FIRING A SHOCK INTO A SHORTED LEAD.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE UPGRADE PROCEDURE, THE SENSING DECREASED ON THE RIGHT VENTRICULAR (RV) LEAD. AFTER THE SENSITIVITY WAS REPROGRAMMED, VENTRICULAR FIBRILLATION (VF) COULD NOT BE DETECTED. AS A RESULT, A NEW PACE/SENSE LEAD WAS IMPLANTED. WHEN A 21J SHOCK WAS DELIVERED, THE VR WAS NOT ELIMINATED. ADDITIONALLY, AN ERROR MESSAGE APPEARED STATING THE DEVICE BATTERY WAS DEPLETED. A SECOND DEVICE (P143/104368) WITH THE SAME RV LEAD WAS IMPLANTED AND THE ERROR MESSAGE PERSISTED. THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED. A THIRD DEVICE WAS IMPLANTED WITH A NEW RV LEAD AND THE DEVICE AND LEAD BOTH OPERATED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313421 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P143

    Patients

    Seq Age Sex Outcome Treatment
    1