BEUDAMED
    FDA Adverse Event Death Summary report: N

    Capsure® EPI

    MDR report key: 2921884 · Received January 18, 2013

    Report

    Report Number
    2649622-2013-00041
    Event Type
    Death
    Date Received
    January 18, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: DEVICE EVALUATED BY MFR?: NO, EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEAD HAD HIGH THRESHOLDS AND IMPEDANCE. THE LEAD WAS REPLACED WITH A NEW LEAD. IT WAS ALSO REPORTED THAT AFTER THE LEAD WAS REPLACED THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REQUESTED AND REPORTED AS ELECTROMECHANICAL DISSOCIATION WITH THE LEAD MALFUNCTION REPORTED AS NOT DIRECTLY CONNECTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28434 Capsure® EPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00002 YR Death 4968 IMPLANTABLE PACING LEAD