BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3973823 · Received August 1, 2014

    Report

    Report Number
    2649622-2014-07681
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SEROMA (A COLLECTION OF FLUID UNDER THE SKIN, USUALLY AT THE SITE OF A SURGICAL INCISION) ABOUT A YEAR AFTER THE DEVICE IMPLANTATION. IT WAS NOTED THAT THE PATIENT HAD AN ALLERGIC REACTION. THERE WAS NO INFECTION REPORTED AND THE PHYSICIAN SUSPECTS THE ALLERGIC REACTION IS RELATED TO THE LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE AND THE PATIENT IS STILL HOSPITALIZED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450321 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00002 YR Hospitalization REDR01 IPG, 6948 LEADS X2