BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3092648 · Received May 3, 2013

    Report

    Report Number
    1644487-2013-01234
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE PATIENT HAD HIS DEVICE EXPLANTED ON (B)(6) 2013 DUE TO AN INFECTION OVER THE GENERATOR POCKET. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, NO OTHER INFORMATION HAS BEEN PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE GENERATOR AND LEAD CONFIRMED BOTH GENERATOR AND LEAD MET ALL FINAL TESTING SPECIFICATIONS AND STERILIZATION STANDARDS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194941 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 202243

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other