BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 13067824 · Received December 22, 2021

    Report

    Report Number
    1644487-2021-01809
    Event Type
    Death
    Date Received
    December 22, 2021
    Date of Event
    November 18, 2021
    Report Date
    March 11, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 LIVANOVAEMPLOYEES 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 THE PATIENT HAS PASSED AWAY. NO DATE OR REASON FOR DEATH WAS GIVEN. HE HAD BEEN HOSPITALIZED FOR A COUPLE OF MONTHS PRIOR. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE PATIENT HAD CONCURRENT ILLNESS AT TIME OF DEATH OF CEREBRAL PALSY, SMALL BOWEL OBSTRUCTION, GARRETT'S ESOPHAGUS, SEPTIC SHOCK R/T INTRAABDOMINAL INFECTION R/T COLECTOMY. BELIEVED CAUSE OF DEATH WAS NOTED AS SEQUELAE OF SEPTIC SHOCK FOLLOWING SMALL BOWEL OBSTRUCTION / TOTAL COLECTOMY. BELIEVED RELATIONSHIP TO VNS IS NOT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962447 PULSE GEN MODEL 102R GENERATOR LYJ LIVANOVA USA, INC. 102R 203011

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death