BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3905285 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10642
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED....

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD AND PACEMAKER DISPLAYED LOSS OF CAPTURE THAT RESULTED IN PACING PAUSES LASTING APPROXIMATELY FOUR SECONDS. TWO MONTHS EARLIER, THIS LEAD HAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED. THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED. THIS DEVICE REMAINS IMPLANTED. POST PROCEDURE, ACCEPTABLE MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382088 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R K183| 4087| 4088