BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3050161 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03610
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE NOISE WAS UNABLE TO BE DETERMINED AT THIS TIME. THE LEAD SENSITIVITY WAS REPROGRAMMED TO THE LEAST SENSITIVE SETTING AND DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. ADEQUATE SENSING AND DFTS WERE DEMONSTRATED. THE PATIENT WILL CONTINUE TO BE MONITORED THROUGH ROUTINE FOLLOW-UP APPOINTMENTS AND REMOTE MONITORING. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IMPLANTED WITH ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD, EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. THE NOISE WAS OVERSENSED WITH RESULTED IN GREATER THAN 200 NONSUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES AND PACING INHIBITION. IT WAS REPORTED THE PATIENT IS PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS OR SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149081 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R MISMATCH| N141| 1488TC| H217| 4543| 1580