BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3151336 · Received June 7, 2013

    Report

    Report Number
    1644487-2013-01704
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 20, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCORRECT AWARE DATE OF (B)(4) 2013 WAS INADVERTENTLY REPORTED ON THE INITIAL MDR REPORT. THE CORRECT AWARE DATE IS PROVIDED AS (B)(4) 2013.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT WAS HOSPITALIZED FOR VOMITING FOLLOWING AN INCREASE IN VNS SETTINGS FROM 0.25 MA TO 1.25 MA. THE VOMITING WAS ALSO OCCURRING WHEN THE PATIENT TOOK HIS MEDICATIONS. THE PATIENT HAD RECENTLY HAD VNS GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. THE PATIENT DID NOT HAVE A HISTORY OF VOMITING OR DYSPEPSIA. THE PLAN OF CARE WAS TO DISABLE THE VNS GENERATOR FOR A FEW DAYS, BUT IT IS UNKNOWN IF THIS OCCURRED. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND THE GENERATOR WAS STILL ENABLED AT 1.25 MA AT THAT TIME, AND THE VOMITING HAD RESOLVED. THE PATIENT¿S MEDICATION WAS ALSO REDUCED. VNS DIAGNOSTICS WERE REPORTED TO BE WITHIN NORMAL LIMITS PER THE REPORTER. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253348 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 202296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R