BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 9807564 · Received March 9, 2020

    Report

    Report Number
    1644487-2020-00411
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 9, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYCARDIA, PROLONGED QTC INTERVALS AND EAR PAIN WITH VNS STIMULATION. THE PATIENT WAS IN TWO CAR ACCIDENTS IN THE PAST 18 MONTHS, PER THE PHYSICIAN. IT WAS REPORTED THAT THE CARDIOLOGIST INSISTED THAT THE VNS CONTRIBUTED TO THE REPORTED HEART RATE ISSUES; HOWEVER THE NEUROLOGIST INDICATED THAT THEY DID NOT BELIEVE THE VNS TO BE THE CAUSE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270116 PULSE GEN MODEL UNK GENERATOR MUZ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other