BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3771548 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-04826
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    February 16, 2014
    Report Date
    May 14, 2014
    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

    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, 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA THE PATIENT¿S REMOTE HOME MONITORING SYSTEM THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE IMPEDANCE MEASUREMENTS OF THE RV LEAD HAD INCREASED FOR THE PAST FIVE YEARS. THE DEVICE FUNCTION AND PACING PARAMETERS WERE STILL IN NORMAL RANGE AS OF THE CURRENT EVALUATION. THE PATIENT WAS SENT FOR SYSTEM UPGRADE AND DID QUALIFY UPON SCREENING. AT THIS TIME, THE PATIENT WILL FOLLOW-UP WITH THE FACILITY THAT IS CAPABLE FOR THE SYSTEM UPGRADE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE RV LEAD WAS SURGICALLY ABANDONED DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE ICD WAS ALSO EXPLANTED DURING THE PROCEDURE DUE TO AN UPGRADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249102 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R E141| 0158| 1860