BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2964441 · Received February 15, 2013

    Report

    Report Number
    2182208-2013-00433
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 29, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT PRODUCT: 4968 IMPLANTABLE PACING LEAD (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOLTER MONITOR DOCUMENTED THAT THE VENTRICULAR EPICARDIAL LEAD HAD INTERMITTENT CAPTURE FAILURE IN THE PACEMAKER DEPENDENT PATIENT. IT WAS ALSO REPORTED THAT WHEN THE PATIENT WAS IN THE PRONE POSITION VENTRICULAR CAPTURE FAILURE WAS ALSO OBSERVED. THEREFORE THE VENTRICULAR LEAD WILL BE ABANDONED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67103 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER