BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3223623 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10202
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WHICH WAS DETECTED VIA THE PATIENT'S REMOTE MONITORING SYSTEM. THE FIELD REPRESENTATIVE PERFORMED TESTS TO CHECK THE SHOCK LEAD IMPEDANCE AND IT GAVE DIFFERENT MEASUREMENTS FROM POCKET MANIPULATION AND DIFFERENT PATIENT POSITIONS. THE FIELD REPRESENTATIVE CHANGED THE SHOCK CONFIGURATION TO DISTAL COIL TO CAN AND DID ALL THE TESTS AGAIN. TEST RESULTS WERE WITHIN NORMAL LIMITS. NOISE WAS ALSO OBSERVED ON THE SHOCK ELECTROGRAM (EGM). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THERE WAS A LEAD INTEGRITY ISSUE ON THE PROMIXAL END OF THE LEAD. A LEAD FRACTURE WAS SUSPECTED. AS A RESOLUTION, THE DEVICE'S SHOCK VECTOR WAS PROGRAMMED DISTAL COIL TO CAN AND SHOCK OUTPUTS WERE SET TO MAX. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322624 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0185| T180| 4471| E143