BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2852533 · Received November 30, 2012

    Report

    Report Number
    1644487-2012-03156
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 30, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012, STATED IN THE PATIENT'S "ACTIVE MEDICATIONS", THAT THE PATIENT WAS TO GET ATIVAN 2MG BY IV 30 MINUTES PRIOR TO CHEMOTHERAPY. FURTHER INVESTIGATION WITH THE PHYSICIAN REVEALED THAT THE PATIENT DOES NOT HAVE CANCER AND IS NOT "BEING TREATED FOR CHEMOTHERAPY." THE MEANING OF THIS IS UNCLEAR. THE PHYSICIAN'S OFFICE INDICATED THAT THE PATIENT ONLY HAS A FAMILY HISTORY OF CANCER, AND THE PATIENT DOES NOT HAVE CANCER. IT IS UNKNOWN WHY THE CLINIC NOTES INDICATE THAT THE PATIENT IS RECEIVING ATIVAN PRIOR TO CHEMOTHERAPY. ATTEMPTS FOR FURTHER CLARIFICATION WERE UNSUCCESSFUL, AS THE REASON THE PATIENT RECEIVES CHEMOTHERAPY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP WAS PERFORMED WITH A NURSE AT THE TREATING PHYSICIAN'S OFFICE ON (B)(6) 2012 TO OBTAIN CLARIFICATION ON WHY THE PATIENT RECEIVES ATIVAN "MINUTES BEFORE CHEMOTHERAPY." THE NURSE LOOKED AT THE PATIENT'S RECORDS AND REPORTED THAT IN THE PATIENT'S "HMP" AND CANCER DIAGNOSIS, THERE IS NO INDICATION THAT THE PATIENT HAS/HAD CANCER OR IS BEING TREATED WITH CHEMOTHERAPY. THE NURSE INDICATED THAT THE NOTES DATED (B)(6) 2012 LIKELY REPORTED IN ERROR THAT THE PATIENT RECEIVES CHEMOTHERAPY, AS THERE IS NO RECORD OF THE PATIENT RECEIVING CHEMOTHERAPY IN THEIR RECORDS AND THE PATIENT DOES NOT HAVE CANCER. IN ADDITION, SHE REPORTED THAT THERE IS NO PATHOLOGY IN THE CHART THAT WOULD INDICATE THAT THE PATIENT IS RECEIVING CHEMOTHERAPY. IT WAS ALSO CONFIRMED THAT THE ATIVAN IS PRESCRIBED FOR THE PATIENT'S SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2624

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention