BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2945161 · Received February 6, 2013

    Report

    Report Number
    2124215-2013-02577
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 10, 2012
    Report Date
    March 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    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

    BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THESE PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SHOCKING VECTOR HAD BEEN REPROGRAMMED TO RV COIL TO CAN. HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE LATER OBSERVED IN THIS SHOCKING VECTOR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED MONITORING THE SHOCK IMPEDANCE MEASUREMENTS AND TESTING OPTIONS IF MEASUREMENTS CONTINUE TO INCREASE. 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 HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS DURING IMPLANT TESTING IN ALL SHOCKING VECTORS. THE CONNECTIONS WERE CHECKED AND WERE CONFIRMED TO BE SECURE. DEFIBRILLATION THRESHOLD (DFT) TESTING AND COMMANDED SHOCKS WERE PERFORMED IN TRIAD AND YIELDED MEASUREMENTS OF 83 OHMS. A SAVE TO DISK AND MEMORY DUMP WERE PERFORMED TO DETERMINE THE CAUSE OF THE HIGH OUT OF RANGE MEASUREMENTS. ANALYSIS OF THE SAVE TO DISK AND MEMORY DUMP REVEALED THE MEASUREMENTS WERE OUT OF RANGE WITH THE PROXIMAL COIL. MEASUREMENTS WERE WITHIN RANGE IN RV COIL TO CAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50467 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR E143| 4470| 0184| T167