BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3002065 · Received March 13, 2013

    Report

    Report Number
    1644487-2013-00692
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 21, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE PLAN IS TO TURN THE DEVICE ON, AND THE NEUROLOGIST PLANNED TO PERFORM ANOTHER TEST TO CONFIRM THE INFECTION WAS NO LONGER PRESENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO AN UNCLEAR REASON. THE PATIENT DID NOT HAVE A FEVER BUT WAS BEING MONITORED BY A PEDIATRICIAN AND INFECTIOLOGIST. FURTHER INFORMATION RECEIVED ON (B)(6) 2013 REVEALED THAT THE PATIENT WAS RECOVERING WELL AND WAS FINE AFTER SIGNS OF INFECTION. THE PATIENT REPORTEDLY DEVELOPED A FEVER BUT HAD SINCE DECREASED. THE SIGNS OF INFECTION HAD ENDED. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 AFTER SIGNS OF INFECTIONS AT THE GENERATOR SITE WERE OBSERVED A FEW DAYS PRIOR. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PHYSICIAN BELIEVED THAT THERE WAS NO RELATIONSHIP OF THE INFECTION WITH THE GENERATOR, AS THE GENERATOR WAS NOTED TO BE STERILE AND THE INFECTION WAS DUE TO S. AUREUS. THE INFECTION IS BELIEVED TO BE DUE TO "POST-SURGICAL CARE", BUT IT IS NOTED THAT IT IS DIFFICULT TO DETERMINE EXACTLY. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED/CONTRIBUTED TO THE INFECTION. FURTHER FOLLOW-UP WITH THE NEUROSURGEON ON (B)(6) 2013 REVEALED THAT THE INFECTION WAS ALMOST CLINICALLY ENDED, AND THERE WERE NO POSITIVE CULTURES ANYMORE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFECTION HAS CLINICALLY RESOLVED AND THE DEVICE HAS BEEN PROGRAMMED BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104663 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202019

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention