BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3860373 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05467
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 25, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 MEDICAL PRODUCTS: A 4557M LEAD IMPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED PERSISTENT DIZZINESS AND A HEART RATE OF 35 BPM DURING AN INTERNATIONAL FLIGHT. IT WAS FURTHER REPORTED THAT THERE WAS A SUDDEN PACING FAILURE AND THE "PACEMAKER DID NOT PACE ANYMORE". THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342782 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4023

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SDR303U47 IPG