BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 7093165 · Received December 7, 2017

    Report

    Report Number
    2649622-2017-14634
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    October 26, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169448865
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: 457453 LEAD, IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE POCKET WAS CLOSED, THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS DISLODGED. THE POCKET WAS REOPENED. THE RV LEAD WAS REPOSITIONED SUCCESSFULLY AND REMAINS IN USE. THE RA LEAD WAS UNABLE TO BE REPOSITIONED, BECAUSE THE TINES ON ANOTHER CHRONIC LEAD CAPTURED THE RA LEAD AND WEDGED IT INTO THE RIGHT SUBCLAVIAN VEIN. THE RA LEAD WOULD NOT MOVE AFTER MULTIPLE ATTEMPTS, AND IT WAS INACTIVATED. THE RA LEAD REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872591 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458 00643169448865

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R VEDR01 IPG