BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3921822 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13118
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT EXPECTED TO BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW, OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENT OF 100 OHMS. NOISE AND LOSS OF CAPTURE (LOC) WERE ALSO OBSERVED. ADDITIONAL INFORMATION RECEIVED THAT SUBCLAVIAN CRUSH WAS SUSPECTED TO BE THE CAUSE OF NOISE AS IT WAS DIFFICULT TO IDENTIFY UNDER FLUOROSCOPY. THE LEAD WAS STILL CAPTURING AT HIGH OUTPUTS. THE LEAD WAS SURGICALLY ABANDONED WHILE THE PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399846 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4137| 4088| 4470| S606| 1284