BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3955874 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-12503
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    May 11, 2014
    Report Date
    September 22, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ANOTHER ALERT WAS DETECTED FOR HIGH, OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENT. THE PHYSICIAN NOTED A NICK ON LEAD'S SHOCKING ELECTRODE. FURTHERMORE, AN ALERT FOR VENTRICULAR TACHYCARDIA (VT) MODE SET TO MONITOR ONLY (MO) WAS ALSO DETECTED. ALERT FOR HIGH SHOCK IMPEDANCE HAS BEEN AN ONGOING ISSUE AND THE FIELD REPRESENTATIVE STATED THAT DEVICE WAS SET TO MO MODE DUE TO PATIENT ENTERING HOSPICE. THE LEAD WAS EXPLANTED WHILE THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS LATER EXPLANTED. THE DEVICE REMAINED IN SERVICE POST LEAD REPLACEMENT WITHOUT FURTHER COMPLICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENT DETECTED VIA THE PATIENT REMOTE MONITORING SYSTEM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. AS OF THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433522 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R H175| 4518| 4472| MISMATCH| N118| N141