BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3971339 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14835
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    February 1, 2014
    Report Date
    July 9, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR) SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED POSSIBLE CAUSES AND PROVIDED MEASURES FOR TROUBLESHOOTING. SUBSEQUENTLY, POST LEAD REVISION, THE FIELD REPRESENTATIVE REPORTED THAT THE CONNECTION TO HEADER WAS CHECKED AND WAS FINE. RV COIL WAS ALSO TESTED WITH THE PACING SYSTEM ANALYZER (PSA) AND NOTED NOISE AND NO PACING AT ALL. HENCE, THE PHYSICIAN OPTED TO REPLACE THE LEAD; HOWEVER, THE HELIX COULD NOT BE RETRACTED SO THE LEAD WAS THEN SURGICALLY ABANDONED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO IRREGULARITIES WERE OBSERVED UNDER FLUOROSCOPY. THE COMPETITOR'S RV LEAD WAS EXPLANTED WHILE THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446954 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R MISMATCH