BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSFIX PU SCR.-IN

    MDR report key: 2955602 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01505
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 12, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT PRODUCT: 4074 IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WARNING TRIGGERED FOR LOW IMPEDANCE. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD APPEARS TO BE WORKING APPROPRIATELY. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57918 CAPSFIX PU SCR.-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Life Threatening ADDRL1 IMPLANTABLE PACEMAKER