BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 8573312 · Received May 2, 2019

    Report

    Report Number
    1644487-2019-00836
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 2, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: INITIAL MDR INADVERTENTLY REPORTED LYJ (EPILEPSY) INSTEAD OF MUZ (DEPRESSION).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THIS PHYSICIAN THAT PATIENT HAD VOCAL CORD PARALYSIS THAT "RANDOMLY CAME UP." THE PATIENT DID NOT HAVE A CHANGE IN SETTINGS AND THE PHYSICIAN DID NOT KNOW THE REASON FOR THE VOCAL CORD PARALYSIS, OR THE DATE THAT IT HAD STARTED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367524 LEAD MODEL 302 LEAD MUZ LIVANOVA USA, INC. 302-20 011314

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other