BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4831538 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05505
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE ATRIAL LEAD DISLODGED AND WAS REIMPLANTED IN THE SAME POSITION. AFTER THE INCISION SITE WAS SUTURED SHUT, THE RIGHT VENTRICULAR LEAD WAS DISCOVERED TO BE DISLODGED. THE LEAD WAS REIMPLANTED WITH GOOD RESULTS AND REMAINS IN USE. WHILE REIMPLANTING THE VENTRICULAR LEAD, THE ATRIAL LEAD DISLODGED A SECOND TIME. THE ATRIAL LEAD WAS REMOVED AND REPLACED WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374649 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R ADDR01 IPG, 5076 LEAD