BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2951646 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00168
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PHYSICIAN EXERCISED THE LEAD PRIOR TO IMPLANT THE HELIX WAS NOT ABLE TO BE FULLY RETRACTED, AND NOTED THAT IT WAS VERY DIFFICULT TO VISUALIZE. 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
    56043 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR