BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 4013062 · Received August 15, 2014

    Report

    Report Number
    2649622-2014-10251
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 7, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 DURING THE IMPLANT PROCEDURE WHEN THE LEAD WAS INITIALLY SUTURED ON, THE LEAD TESTED WELL WITH THE ANALYZER. HOWEVER, ONCE THE LEAD WAS CONNECTED TO THE COMPETITOR DEVICE AND THE SURGEON BEGAN TO CLOSE THE CHEST, THRESHOLD AND IMPEDANCE INCREASED. THE CONNECTION WAS CHECKED AT THE DEVICE HEADER TO ENSURE THE LEAD WAS PROPERLY SEATED. THE LEAD WAS NOT IMPLANTED AND A NEW LEAD OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED AND USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489586 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ST JUDE IPG