BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE 0185/202763 IMPLANTED 11-SEP-2008

    MDR report key: 1384806 · Received February 10, 2009

    Report

    Report Number
    2124215-2009-02215
    Event Type
    Injury
    Date Received
    February 10, 2009
    Date of Event
    September 11, 2008
    Report Date
    August 21, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS ICD WAS THOROUGHLY INSPECTED AND ANALYZED. PIN GAUGE TESTING CONFIRMED THAT ALL PORT DIAMETERS WERE WITHIN DESIGN SPECIFICATION RANGE; HOWEVER, THE DIAMETER OF THE IS-1 RA SPRING CONTACT COMPONENT WAS FOUND TO BE OUT-OF-SPECIFICATION. THIS MAY HAVE RESULTED IN A SUBOPTIMAL CONNECTION WITH THE LEAD TERMINAL. IT IS UNLIKELY THAT THIS LABORATORY FINDING CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS, THE FIELD OBSERVATIONS WERE RESOLVED AT THE TIME THEY WERE NOTED AND WERE UNABLE TO BE REPRODUCED IN THE LAB.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED POSTHUMOUS. THE PATIENT DEATH WAS UNRELATED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS RELATED TO THE DEVICE WERE REPORTED WHILE IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 0185/202763 IMPLANTED 11-SEP-2008 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening