BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1852909 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15627
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    December 8, 2009
    Report Date
    July 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS CONFIRMED THAT THE LEAD WAS RETURNED SEVERED 20.5 CM FROM PIN; THE PROXIMAL SEGMENT ONLY WAS RETURNED. THERE WERE SET SCREW MARKS NOTED ON TERMINAL PIN AND RING. DC RESISTANCE TEST SHOWED RETURNED SEGMENT OF LEAD IS CONTINUOUS. BOTH THE MECHANICAL AND THE ELECTRICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WERE SCRUTINIZED. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WITH THIS PACEMAKER PASSED AWAY LATE LAST YEAR. BOSTON SCIENTIFIC RECENTLY RECEIVED A COPY OF THE DEATH CERTIFICATE WHICH LISTED THE CAUSES OF DEATH TO BE UREMIA, END STAGE RENAL FAILURE AS WELL AS ENDOCARDITIS. THE DEVICE AND LEADS HAVE BEEN RETURNED TO BOSTON SCIENTIFIC AND WILL BE ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death 1291| 4087| 4086