BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3910018 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-08418
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 8, 2014
    Report Date
    March 10, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL INFORMATION WAS RECEIVED APPROXIMATELY 3 YEARS LATER THAT NOISE CONTINUED TO BE OBSERVED ON THE RV CHANNEL. AN INVASIVE PROCEDURE WAS PERFORMED. THE PACEMAKER WAS EXPLANTED AND THE RV LEAD WAS SURGICALLY ABANDONED. DUE TO THE PATIENT BEING OCCLUDED, A NEW SYSTEM WAS IMPLANTED ON THE OPPOSITE SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND PACEMAKER EXHIBITED LOW PACE LEAD IMPEDANCE MEASUREMENT LESS THAN 200 OHMS ALONG WITH UNDERSENSING AND HIGH PACING THRESHOLD MEASUREMENTS. NOISE WAS REPRODUCED WITH ISOMETRICS. A SUBSEQUENT LEAD REVISION WAS ATTEMPTED BUT WAS UNSUCCESSFUL DUE TO AN OCCLUDED SUBCLAVIAN VEIN. ADDITIONAL INFORMATION INDICATED THAT A FLUOROSCOPIC IMAGE LOOKED A LITTLE SUSPECT IN THE AREA OF THE CLAVICLE BUT WAS NOT CONFIRMED. THE PHYSICIAN WAS CONSIDERING PROGRAMMING THE DEVICE TO AAI. AT THIS TIME, NO REVISION HAS BEEN SCHEDULED YET. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387698 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4087| S606