BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2952323 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00500
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 1, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THERE WAS NO CAPTURE AND HIGH IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS ENROLLED IN THE (B)(4). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56564 SCREW-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 5071 IMPLANTABLE PACING LEAD