BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4162497 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12749
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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: SEDR01 IPG, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS CAPPED AND REPLACED FOR A FAILURE AT THE TIME OF THE DEVICE CHANGE FOR ELECTIVE REPLACEMENT INDICATOR. THE LEAD THEN MIGRATED AND WAS PULLED BACK AND RE-CAPPED ABOUT THREE WEEKS LATER. THE PATIENT ALSO HAS HAD A RASH ALL OVER THEIR BODY FOR NINE MONTHS. THE PATIENT IS UNDER THE CARE OF AN ALLERGIST WHILE A DETERMINATION IS BEING MADE AS TO WHETHER THE REACTION IS FROM THE DEVICE OR LEADS. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643442 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 559445

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 5092 LEAD