BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 3993840 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09097
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K883743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND WAS UNDERSENSING. THE LEAD WAS REPROGRAMMED TO OVERDRIVE PACE THE PATIENT'S UNDERLYING RHYTHM TO MITIGATE THE ISSUE OF UNDERSENSING IN BIPOLAR. 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
    470952 TRANSVENOUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4058M58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SSR303B IPG