BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL PORT ACCESS DEVICE

    MDR report key: 101042 · Received June 26, 1997

    Report

    Report Number
    MW1011569
    Event Type
    Injury
    Date Received
    June 26, 1997
    Report Date
    May 21, 1997
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE MEDWATCH FORM APPEARS TO BE INITIATED BY A FORMER IMPLANTEE AND NOW LITIGANT. THE EVENT DESCRIBED WAS PREVIOUSLY REPORTED UNDER MDR FDA ACCESS NO. M-755206, APRIL 19, 1996, WITH WRITTEN REPORT SENT ON MAY 2, 1996. THE EXPLANT OF THE CATHETER OCCURRED ON JUNE 29, 1995. THAT REPORT WAS TRIGGERED BY A TELEPHONE CALL FROM THE PT TO FIRM IN WHICH HE ASKED FOR "MONEY FOR PAIN AND SUFFERING" ON APRIL 9, 1996. THE MEDWATCH REPORT JUST RECEIVED CONTAINS NO USEFUL ADD'L INFO COMPARED TO MDR M-755206. THEREFORE, CO BELIEVES NO FURTHER SUBMISSION IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL PORT ACCESS DEVICE Implant IMPLANTED CATHETER LJT COOK PACEMAKER CORP. 5116W *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R| S