BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 15486528 · Received September 26, 2022

    Report

    Report Number
    1644487-2022-01192
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 26, 2022
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A CLUSTER OF SEIZURES THE NIGHT PRIOR AND HAD TO CALL AN AMBULANCE AS SHE WAS HAVING RESPIRATORY DISTRESS AND GOT REALLY SCARED. SHE STATED THAT SHE KNOWS THE GENERATOR STILL HAS BATTERY IN IT BUT WOULD LIKE FOR THE SURGERY DATE TO BE MOVED SOONER IF POSSIBLE. PATIENT HAD REPLACEMENT SURGERY. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956124 PULSE GEN MODEL 1000 GENERATOR LYJ CYBERONICS - HOUSTON 1000 205256 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention