BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953672 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01269
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 PATIENT HAD "DEVELOPED INCREASING SYMPTOMS OF HEART FAILURE" WITH A DEVICE AT ELECTIVE REPLACEMENT INDICATOR. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASED THRESHOLD AND DECREASED IMPEDANCE. THE LEFT VENTRICULAR LEAD WASALSO NOTED TO HAVE NO CAPTURE. THE LEADS WERE CAPPED AND REPLACED. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57124 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD