BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302-20

    MDR report key: 1761250 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01642
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT'S DIAGNOSTICS RESULTS SHOWED HIGH LEAD IMPEDANCE ON ONE READING; HOWEVER, ON THE NEXT TEST, DIAGNOSTICS SHOWED EVERYTHING WORKING WITHIN NORMAL LIMITS. COMPANY REP WENT TO THE SITE TO FIND OUT MORE INFO ABOUT THE ISSUE, BUT THE PT WAS NOT PRESENT IN THE OFFICE AT THAT TIME. COMPANY REP WENT THROUGH THE PHYSICIAN'S HANDHELD AND DID NOT FIND ANY HIGH IMPEDANCE DATA IN THE LAST 25 READINGS; HOWEVER, DATES ON THE HANDHELD WERE INCORRECT THEREFORE, LAST 25 READINGS PROBABLY WOULD NOT HAVE THE RECENT TESTS. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302-20 LYJ CYBERONICS, INC. 302-20 2205

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR