BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2884071 · Received December 21, 2012

    Report

    Report Number
    6000030-2012-00232
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 5, 2012
    Report Date
    February 14, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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. (B)(4). THE MANUFACTURING DATE WAS REQUESTED AND NOT RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PACEMAKER REPLACED DUE TO THE LEAD. IT WAS FURTHER REPORTED THAT THE PACING SYSTEM WAS "REVISED DUE TO INTERMITTENT LOSS OF CAPTURE AT HIGH OUTPUTS" ON THE PACING LEAD, WHICH WAS RECORDED ON A HOLTER MONITOR. THE PATIENT WAS "UNAWARE" OF THE INTERMITTENT LOSS OF CAPTURE. DURING THE OPERATIVE PROCEDURE THE LEAD WAS CUT, "REMOVED ENTIRELY AND DISCARDED." THERE WERE NO KNOWN PHYSICAL COMPLICATIONS RELATED TO THIS EVENT, BUT IT WAS NOTED THAT THE PATIENT NOW HAS INCREASED ANXIETY REGARDING THE PACEMAKER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 10366

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Hospitalization| R