BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2993544 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00623
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013, THAT A PATIENT'S VNS DEVICE INDICATED HIGH LEAD IMPEDANCE WITH AN IMPEDANCE VALUE GREATER THAN 10000 OHMS. THE PATIENT WAS ALSO EXPERIENCING PAIN AT AN UNKNOWN LOCATION. THE HIGH IMPEDANCE EVENT WAS BELIEVED TO BE RELATED TO TRAUMA, WHERE THE PATIENT FELL OFF OF A PLAYGROUND SLIDE WHICH CAUSED THE LEAD PIN TO LOOSEN UP. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013, IN WHICH THE LEAD PIN WAS REINSERTED INTO THE GENERATOR. AFTER DOING SO, THE HIGH IMPEDANCE ISSUE WAS RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PAIN EVENT WERE MADE, IN WHICH NO CONCLUSIONS COULD BE DRAWN. ATTEMPTS FOR ADDITIONAL PROGRAMMING AND DEVICE DIAGNOSTIC HISTORY HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98222 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202155

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention