BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3991220 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08236
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NOT CAPTURING. DURING AN EXTRACTION ATTEMPT THE LEAD WAS ADHERED TO ANOTHER LEAD. THE LEAD WAS INACTIVATED AND WAS SUBSEQUENTLY LASER EXTRACTED 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
    468015 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R VEDR01 IPG, 5076 LEAD