BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS THERAPY PATIENT ESSENTIALS

    MDR report key: 9750538 · Received February 24, 2020

    Report

    Report Number
    MW5093246
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    December 12, 2019
    Report Date
    February 20, 2020
    Manufacturer
    CYBERONICS, INC. / LINOVA USA, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER WAS HAVING A VNS STIMULATOR OUTPATIENT. SHE HAS MANY UNDERLINE CONDITIONS LIKE CP, ASTHMA, EPILEPSY AND IS ALSO WHEELCHAIR BOUND. SURGERY TOOK 3 HRS. RATHER THAN 90 MIN AT MOST. I WAS NOT TOLD AT ALL ABOUT HER ASPIRATING UNTIL 2 WEEKS SHE HAD AND WAS VOMITING VIOLENTLY AND WAS TOLD IT WAS THE ANESTHESIA, SHE WOULD BE OK SHE WINDED UP WITH ASPIRATION OF PNEUMONIA BILATERAL PNEUMONIA AS WELL. THE ANESTHETIC WAS OBVIOUSLY AND ALMOST KILLED HER BUT WAS NOT EVEN TOLD HOW BAD SHE WAS DURING THE OPERATION. THEY LET HER GO HOME NOT EVEN A SPOON OF APPLE SAUCE AND NO WRITING OF HER EFFECT BY ANY OF THE HOSP STAFF. THEY MEANS ANESTHESIOLOGIST AND SURGEON. I AM SCARED FOR MY DAUGHTER'S LIFE. WHAT WENT WRONG AND ABUSE OF A DISABLED PERSONS PSYCHOLOGICAL STATUS WAS NOT AT ALL IN CONSIDERATION AND I AM STILL "TILL" TODAY HAVE PROBLEMS WITH HER. ASPIRATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211502 VNS THERAPY PATIENT ESSENTIALS STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY LYJ CYBERONICS, INC. / LINOVA USA, INC. 1000 2290895

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O| R| S