BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2955136 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00829
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH 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. CONCOMITANT PRODUCTS: 5024M IMPLANTABLE PACING LEAD (B)(6) 1994. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON INTERROGATION IT WAS NOTED THAT THE SHORT INTERVAL COUNTS (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD WERE ELEVATED. SENSING, CAPTURE, AND IMPEDANCES WERE ACCEPTABLE. THE SENSITIVITY WAS ADJUSTED AND THERE WERE NO ISSUES AT THE NEXT CHECKUP. THE 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
    59748 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention P1501DR IMPLANTABLE PULSE GENERATOR (IPG)