BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3053207 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05526
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CHANGES TO THE ICD'S PROGRAMMING WAS MADE AS THE DEVICE WAS OPERATING NORMALLY AND IT WAS ONLY ONE LOW P-WAVE THAT RESULTED IN ATP DELIVERY. THE ICD REMAINS IMPLANTED AND IN SERVICE. 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SEVERAL ROUNDS OF ANTI-TACHYCARDIA PACING (ATP) AFTER THE VENTRICULAR RATE APPEARED TO BE FASTER THAN THE ATRIAL RATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED TO REVIEW THE DATA FROM THE REMOTE MONITORING SYSTEM. THE TS CONSULTANT DISCUSSED THAT THE PATIENT WAS EXPERIENCING AN SUPRAVENTRICULAR TACHYCARDIA (SVT) AND THE ICD WAS INHIBITING THERAPY DELIVERY APPROPRIATELY. HOWEVER, ONE P-WAVE IS THEN UNDERSENSED BY THE DEVICE DUE TO THE LOW MORPHOLOGY THAN THE PREVIOUS P-WAVES AND THE DEVICE THEN DELIVERED ATP PER PROGRAMMING UNTIL THERAPY WAS EXHAUSTED IN THE EPISODE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154425 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 1831| 4053| T127| MISMATCH| E143| 0041| 0144