BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3990073 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08831
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS ATTEMPTED BUT THE PHYSICIAN FELT THE HELIX DID NOT EXTEND. THE LEAD WAS REMOVED FROM THE PATIENT AND THE HELIX DID NOT DEPLOY. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465187 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR