BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3213642 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09337
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT HAVING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD AN OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE ISSUES (UNKNOWN VALUE) AND SOME PACEMAKER MEDIATED TACHYCARDIAS (PMTS) DURING DEVICE INTERROGATION. THE PATIENT WAS COMPLAINING OF SHORTNESS OF BREATH (SOB) HOWEVER THE HEALTHCARE PROFESSIONAL (HCP) THOUGHT IT WAS NOT RELATED TO THE ISSUES. TS DISCUSSED THAN AN OOR MAY HAVE HAPPENED BUT IT WAS JUST NOT SHOWING UP IN THE DAILY MEASUREMENTS. TS FURTHER DISCUSSED THAT IT WOULD BE ON THE PHYSICIAN¿S DISCRETION AND MAY CONSIDERED BRINGING THE PATIENT IN FOR EVALUATION. THE HCP WILL TALK TO THE PHYSICIAN. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO INTERVENTION PERFORMED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314360 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR MISMATCH| 4543| 0292| N140