BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2349442 · Received November 28, 2011

    Report

    Report Number
    1644487-2011-02856
    Event Type
    Injury
    Date Received
    November 28, 2011
    Date of Event
    October 27, 2011
    Report Date
    November 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT PATIENT HAD UNDERGONE SURGERY ON (B)(6) 2011 TO REPOSITION THE VNS GENERATOR. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN IT WAS REPORTED THAT THERE WERE NO REPORTS OF PATIENT MANIPULATION OR TRAUMA THAT COULD HAVE CAUSED THE MIGRATION. THE GENERATOR HAD MIGRATED LATERALLY AND WAS INTERFERING WITH SHOULDER MOVEMENT. THIS MIGRATION OF THE GENERATOR APPEARED TO BE CAUSING SOME DISCOMFORT. THE CAUSE FOR THE MIGRATION WAS UNKNOWN AND IT WAS NOTED THAT THE PATIENT HAS DEVELOPMENTAL DELAYS. THE SURGERY WAS STATED TO HAVE OCCURRED TO PRECLUDE A SERIOUS INJURY. (B)(6) ATTEMPTS TO OBTAIN INFORMATION REGARDING THE TYPE OF SUTURE USED BY THE IMPLANTING SURGEON HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2650

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention