BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2964829 · Received February 15, 2013

    Report

    Report Number
    1644487-2013-00423
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT IS BEING TREATED FOR CANCER AND A PORT WAS "INSTALLED" TODAY IN HER LEFT NECK FOR THE CANCER TREATMENT. AFTER THE PROCEDURE, THE PATIENT REPORTED A STINGING SENSATION EACH TIME THE VNS STIMULATION OCCURRED. IT WAS STATED THAT THIS STINGING SENSATION WAS NOT PAINFUL; HOWEVER, IT DID NOT OCCUR PRIOR TO THE PORT PROCEDURE. IT WAS STATED THAT THE PATIENT WOULD BE SEEN THE FOLLOWING WEEK FOR DIAGNOSTIC TESTING AND TO POSSIBLY ORDER X-RAYS. THE PHYSICIAN AND PATIENT WERE INFORMED THAT THEY CAN TEMPORARILY DISABLE THE DEVICE USING THE MAGNET IF NEEDED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IT IS UNKNOWN WHAT THE CAUSE OF THE CANCER IS NOR ITS RELATIONSHIP TO VNS.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN'S OFFICE FOUND THAT THERE WAS NO ASSOCIATION BETWEEN THE CANCER AND VNS. THE CANCER WAS LOCATED IN THE RIGHT BREAST. THE PORT WAS PLACED TO HELP WITH MEDICATION FOR THE CANCER. BESIDES THE PORT, THE PATIENT IS BEING FOLLOWED BY AN ONCOLOGIST FOR INTERVENTIONS. THE PATIENT HAS A MEDICAL HISTORY OF BREAST CANCER. NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHNAGES PROCEEDED THE ONSET OF THE SINGING SENSATION IN THE NECK FROM AFTER THE PORT WAS PLACED. NO PATIENT MANIPULATION OR TRAUMA OCCURRED WHICH IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE STINGING SENSATION. IT WAS STATED THAT A RECENT EVALUATION SHOWED THAT THE PATIENT'S DEVICE WAS FUNCTIONING WELL AND THAT THE STINGING SENSATION SYMPTOMS RESOLVED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67625 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200812

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention