BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3213676 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09039
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 10, 2013
    Report Date
    September 20, 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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT¿S CRT-D EXHIBITED HIGH OOR SHOCK LEAD IMPEDANCE (SLI) VIA THE PATIENT¿S MONITORING SYSTEM. THIS IS AN ON-GOING ISSUE. THE PHYSICIAN HAS NO PLAN FOR SURGICAL INTERVENTION AS SLI MEASUREMENT WAS STILL WITHIN THE PHYSICIAN¿S COMFORT ZONE. THE PATIENT IS CONTINUOUSLY MONITORED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT THAT WAS DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD IS A COMPETITOR'S PRODUCT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A FIELD REPRESENTATIVE INDICATING THAT THE PATIENT CAME IN AND DETERMINED THAT SHOCK IMPEDANCE MEASUREMENT DECREASED BELOW 100 OHMS. AT THIS TIME, COMMANDED SHOCKS WERE NOT PERFORMED TO TEST SYSTEM INTEGRITY. THE PHYSICIAN WILL CONTINUOUSLY MONITOR THE PATIENT AND WILL PROBABLY PERFORM A CHANGE OUT IF SHOCK IMPEDANCE MEASUREMENT BECOMES ELEVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312988 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N164

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 5568| D154ATG| 4518| 6947| N164