BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4092211 · Received August 20, 2014

    Report

    Report Number
    1644487-2014-02048
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 22, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THE INCORRECT SUSPECT MEDICAL DEVICE INFORMATION. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS. MODE, SERIAL#, LOT#, EXPIRATION DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THE INCORRECT SUSPECT MEDICAL DEVICE INFORMATION. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS. DEVICE MANUFACTURE DATE (MO/DAY/YR), CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THE INCORRECT SUSPECT MEDICAL DEVICE INFORMATION. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED THREE DAYS FOLLOWING GENERATOR REPLACEMENT SURGERY FOR TACHYCARDIA. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED TACHYCARDIA PRIOR TO THE REPLACEMENT SURGERY AS WELL. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500672 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202930

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization