BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3736923 · Received April 9, 2014

    Report

    Report Number
    2124215-2014-07964
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    August 29, 2012
    Report Date
    February 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THREE AREAS OF INSULATION DAMAGE WERE NOTED, ALONG WITH A CATHODE CONDUCTOR COIL FRACTURE 223 MILLIMETERS (MM) FROM THE TERMINAL PIN. THE INSULATION WAS DAMAGED 243-258 MM FROM THE TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF DAMAGE IT APPEARS THIS DAMAGE WAS LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE FIRST RIB REGION. INSULATION DAMAGE WAS ALSO NOTED ON THE OPPOSITE SIDE OF THE LEAD BODY, INDICATIVE OF LEAD-ON-LEAD CONTACT. NO FURTHER TESTING COULD BE PERFORMED DUE TO THE DAMAGE TO THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD BEEN PROGRAMMED OFF DUE TO AN UNSPECIFIED REASON. IT WAS REPORTED THE PATIENT DID NOT REQUIRE AN RA LEAD. THE LEAD WAS LATER ELECTIVELY EXPLANTED AND RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215427 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4518| 4087| 0185| H175| N118