BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2812624 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16460
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD A LOW BIPOLAR IMPEDANCE. THE ATRIAL LEAD NOTIFICATION PARAMETER WAS MODIFIED AND THE LEAD REMAINS IN USE. THE LEAD IMPEDANCE WILL BE MONITORED AND THE PATIENT IS DUE BACK IN THE OFFICE IN TWO MONTHS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4058M

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR| 4058M IMPLANTABLE PACING LEAD