BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3211517 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08893
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    December 1, 2016
    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

    THE PHYSICIAN WILL CONTINUE MONITORING. 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

    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

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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. LABORATORY ANALYSIS DID NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED TO AN ELECTROPHYSIOLOGIST FOR FOLLOW UP. SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE WITHIN NORMAL LIMITS AND X-RAY IMAGING SHOWED NO ANOMALIES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. ALL SUBSEQUENT MEASUREMENTS WERE OBSERVED TO BE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INTERMITTENT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS CONTINUE TO BE OBSERVED. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED AND SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE WITHIN NORMAL LIMITS. AN ADDITIONAL CHEST X-RAY WAS PERFORMED AND CONNECTIONS APPEARED ACCEPTABLE. A COPY OF DEVICE MEMORY WAS SUBMITTED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR ANALYSIS. ANALYSIS OF DEVICE MEMORY REVEALED SATURATED SHOCK IMPEDANCE MEASUREMENTS IN RV COIL TO RA COIL AND RA COIL TO CAN. ANALYSIS CONCLUDED AN ISSUE WITH THE PROXIMAL COIL. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS SCHEDULED FOR A DATE IN THE FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND REPLACED 3 YEARS LATER FOR UNRELATED REASONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS CONTINUE TO BE OBSERVED. THE PATIENT WAS SCHEDULED TO SEE AN EP FOR COMMANDED SHOCK TESTING FOR A DATE IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308784 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4479| E142