BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2965066 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02174
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 AN INCREASE IN RIGHT VENTRICULAR (RV) LEAD IMPEDANCE AND A SLIGHT RISE IN THRESHOLD. BUT HAS STABILIZED. IT WAS ALSO NOTED THAT THERE APPEARED TO BE UNDERSENSING OF THE RV LEAD AFTER ANTI-TACHYCARDIA PACING EPISODES. THE RV 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
    69200 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR P1501DR IMPLANTABLE PULSE GENERATOR (IPG)