BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 6263320 · Received January 19, 2017

    Report

    Report Number
    1644487-2017-03053
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 25, 2016
    Report Date
    January 19, 2017
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE RECEIVED CALLS WHILE OUT OF THE OFFICE FROM A PATIENT REPORTING POOR SEIZURE CONTROL AND CONCERNS THAT HER VNS DEVICE WAS NOT WORKING. FOLLOW-UP WITH THE SURGEON WAS PERFORMED, BUT HE WAS UNABLE TO IDENTIFY THE PATIENT AND WAS NEVER ABLE TO ACTUALLY VISIT THE PATIENT. THE NURSE WHO WAS BELIEVED TO BE FOLLOWING THE PATIENT ALSO STATED THAT SHE WAS NOT AWARE OF ANY PATIENT SHARING THIS TYPE OF CONCERN. NO FURTHER RELEVANT INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47728 PULSE GEN MODEL UNKNOWN GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1