BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2864932 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17589
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    September 18, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT DEVICES: 5076 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LOW IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR LEAD AND THE POLARITY SWITCHED. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD HAD HIGH AND VARYING IMPEDANCES, INCREASING THRESHOLDS, AND ATRIAL HIGH RATE EPISODES THAT APPEAR TO BE DUE TO NOISE. THE ATRIAL LEAD WAS PROGRAMMED TO MONITOR ONLY AND THE PATIENT WILL BE SEEN IN A MONTH. BOTH LEADS REMAIN 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
    1 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 E2DR33 IMPLANTABLE PULSE GENERATOR (IPG)