BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3860365 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05462
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. UNKNOWN COMPETITOR IPG IMPLANTED: 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE CHANGEOUT, THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED DUE TO A SUSPECTED FAILURE. THE PHYSICIAN NOTED THAT THE RV LEAD HAD BEEN ATTACHED TO A COMPETITOR DEVICE FOR THE PREVIOUS FOUR YEARS AND THERE WAS A LEAD ISSUE AND HAD BEEN PROGRAMMED UNIPOLAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343110 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Hospitalization| R 4592-45 LEAD