BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC

    MDR report key: 218470 · Received April 7, 1999

    Report

    Report Number
    218470
    Event Type
    Injury
    Date Received
    April 7, 1999
    Date of Event
    December 24, 1998
    Report Date
    March 2, 1999
    Manufacturer
    MEDTRONIC, INC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 67 YEAR OLD WHITE MALE WAS VISITING FAMILY ON 12/24/98. WHILE HAVING DINNER AT A RESTAURANT, GOT ICD SHOCK WHILE EATING. HAD ANOTHER SHOCK AGAIN ON 12/25/98. APPROXIMATELY 2 DAYS LATER, GOT 2 SHOCKS WHICH PROMPTED AN ER VISIT. WAS SENT HOME. NEXT DAY HAD 2 MORE INAPPROPRIATE SHOCKS. PT FLEW HOME ON 1/3/99. ADMITTED THEREAFTER FOR ICD EVALUATION. VENTRICULAR LEAD INFORMATION: REMOVED, SENSING DIFFICULTY, APPARENT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC Implant MEDTRONIC LEAD LWS MEDTRONIC, INC 6966 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R