BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4121677 · Received September 26, 2014

    Report

    Report Number
    1644487-2014-02493
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    March 1, 2014
    Report Date
    August 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEX; CORRECTED DATA: THE INITIAL MDR INADVERTENTLY REPORTED THE PATIENT¿S SEX INCORRECTLY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A GENERATOR REPLACEMENT (B)(6) 2014. THE PATIENT PICKED AT THE INCISION SITE AND HAD A SORE ON THE LEFT SIDE OF INCISION. THE SURGEON WANTED TO GO IN AND RE-CENTER THE GENERATOR. DURING SURGERY WHILE REPOSITIONING THE GENERATOR IT WAS DETERMINED DURING SYSTEM DIAGNOSTICS THAT THE GENERATOR WAS AT END OF SERVICE. AS THE PATIENT WAS RECENTLY IMPLANTED THE END OF SERVICE CONDITION WAS LIKELY DUE TO USE OF ELECTROCAUDARY. THE GENERATOR WAS REPLACED THAT DAY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE GENERATOR MALFUNCTION RELATED TO THE ELECTROCADARY WILL BE REPORTED ON MEDWATCH 1644487-2014-02494.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601639 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3781

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention