BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3143398 · Received June 3, 2013

    Report

    Report Number
    1644487-2013-01655
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET ALL FINAL TESTING SPECIFICATIONS AND STERILIZATION STANDARDS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2013 AND THE PHYSICIAN STATED THAT THE INFECTION IS HEALED AND THE PATIENT WOULD BE SCHEDULED FOR VNS IMPLANT. NO INFORMATION WAS PROVIDED ON WHEN THE ORIGINAL VNS GENERATOR WAS EXPLANTED. IMPLANT SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE GENERATOR MET ALL FINAL TESTING SPECIFICATIONS AND STERILIZATION STANDARDS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REIMPLANT SURGERY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON REPORTED THAT THE PATIENT WAS ADMITTED AND HOSPITALIZED FOR INFECTION. IT WAS STATED THAT THE PHYSICIAN WAS DECIDING WHETHER TO TREAT OR EXPLANT THE CURRENT DEVICE. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245213 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202296

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other