BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2965114 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02164
    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
    MN, US
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASING IMPEDANCES, HIGH IMPEDANCES, AND HIGH THRESHOLDS. THE LEAD WILL BEMO NITORED CLOSELY AND IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2013, IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD ALSO HAD HIGH THRESHOLDS. THE ATRIAL LEAD REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67996 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)