BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 156777 · Received January 5, 1998

    Report

    Report Number
    156777
    Event Type
    Injury
    Date Received
    January 5, 1998
    Date of Event
    November 11, 1997
    Report Date
    January 5, 1998
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ICD LEAD FRACTURE NEAR THE ABDOMINAL POCKET CAUSING INAPPROPRIATE SHOCKS. ICD REPLACED WITH NEW LEAD SYSTEM 11/18/1997 AND NEW ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant PATCH LEAD 6921 LWS MEDTRONIC INC. 6921 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R MEDTRONIC 7217B| MEDTRONIC 6917-35T (X2)