BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3991900 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10094
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    November 12, 2013
    Report Date
    November 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: ADDR01 IPG, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MONTHS POST IMPLANT, THE ATRIAL LEAD HAD HIGH THRESHOLDS AND NO CAPTURE AT HIGH OUTPUTS. THE LEAD WAS INACTIVATED AT THAT TIME AND NOW HAS BEEN CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472095 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 407652 LEAD