BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4160645 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11797
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: A 6932-65 LEAD, IMPLANTED: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE RIGHT ATRIAL (RA) LEAD CAUSING OVERSENSING. THE RA LEAD ALSO HAS HIGH THRESHOLDS THAT ELEVATED OVER TIME. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641473 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5524M-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R D274TRK ICD, 4194-88 LEAD