BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACER LEADS

    MDR report key: 166198 · Received February 26, 1998

    Report

    Report Number
    166198
    Event Type
    Injury
    Date Received
    February 26, 1998
    Date of Event
    February 25, 1998
    Report Date
    February 26, 1998
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT HAD PERMANENT PACER INSERTED ON 9/25/1997. PT NOTED TO HAVE NON-CAPTURE. VENTRICULAR LEAD PLACEMENT GOOD, PROBABLE MICRO-LEAD DISLODGEMENT. PT HAD LEAD EXTRACTED AND NEW LEAD PLACED ON 2/25/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACER LEADS Implant LEADS, PACEMAKER DTB MEDTRONIC, INC. 5034 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R