BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 2954607 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02333
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K883743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. 5524M IMPLANTABLE PACING LEAD 1995 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ELEVATED THRESHOLDS OVER TIME IN THE RIGHT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59708 TRANSVENOUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4058M45

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR,