BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3862303 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06984
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN ONE DAY OF IMPLANT, THERE WAS INTERMITTENT CAPTURE WITH LONG PAUSES OF 7 SECONDS. A TEMPORARY PACING LEAD WAS PLACED UNTIL THE CHRONIC LEAD WAS EXPLANTED 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
    337742 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R ADSR01 IPG