BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3954990 · Received July 24, 2014

    Report

    Report Number
    1644487-2014-01857
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 27, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED VNS PATIENT UNDERWENT SURGERY TO EXPLANT HIS GENERATOR ON (B)(6) 2014. AT THE TIME, IT WAS BELIEVED THAT THE PATIENT HAD DEVELOPED AN INFECTION. IT WAS LATER DETERMINED THAT THE PATIENT DID NOT HAVE AN INFECTION BUT HAD AN ALLERGIC REACTION TO TAPE. THE PATIENT WAS RE-IMPLANTED WITH A NEW GENERATOR ON (B)(6) 2014. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON 07/31/2014. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE PHYSICIAN REPORTED THAT THE PATIENT'S INCISIONS LOOK GREAT AND THERE ARE NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434823 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202613

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention