BEUDAMED
    FDA Adverse Event Summary report: N

    RADIO FREQUENCY ABLATION

    MDR report key: 1003396 · Received February 27, 2008

    Report

    Report Number
    MW5005666
    Date Received
    February 27, 2008
    Date of Event
    March 1, 2006
    Report Date
    February 27, 2008
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT IN MARCH 2006 HER MOTHER RECEIVED RF ABLATION FOR A NON SMALL CELL ANTERIOR LEFT LUNG TUMOR. PT WAS INFORMED THAT SHE WOULD BE THE THIRD PERSON TO RECEIVE THIS TREATMENT BECAUSE IT WAS A NEW APPLICATION OF THIS TECHNOLOGY. THE PROCEDURE WAS UNEVENTFUL, BUT REPORTER STATES THAT HER MOTHER HAD OCCASIONAL PAIN AT THE TUMOR BITE THAT WAS RELIEVED WITH ACETAMINOPHEN. CT AND PET SCANS SHOWED THAT THE TUMOR TRIPLED IN SIZE. PT UNDER WENT 30 TREATMENTS OF "XRT" AND WAS OFFERED CHEMO, HOWEVER, SHE DECLINED. PT EXPIRED JULY 2007. REPORTER STATES THAT SHE IS WILLING TO RELEASE HER MOTHER'S TREATMENT PLAN FOR FURTHER STUDIES FOR THIS TYPE OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIO FREQUENCY ABLATION NONE GEI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR