BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2850785 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03138
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 20, 2009
    Report Date
    October 30, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE LEAD; HOWEVER, THIS IS ACTUALLY THE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THIS VNS PATIENT UNDERWENT FULL REVISION IN (B)(6) 2009 DUE TO PAIN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 THAT THE PATIENT UNDERWENT LEAD AND GENERATOR REVISION DUE TO THE LEAD BEING DETACHED FROM THE GENERATOR. THE PATIENT AWOKE FROM SLEEPING AND NOTED A PAIN. THE PATIENT WAS SEEN ON (B)(6) 2009. IT IS UNKNOWN HOW THE PHYSICIAN DETERMINED THE LEAD TO BE DETACHED FROM THE GENERATOR. NO DIAGNOSTICS WERE AVAILABLE, AND IT IS UNKNOWN IF X-RAYS WERE TAKEN. THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2009. NO OTHER INFORMATION WAS AVAILABLE. THE EXPLANTED DEVICES WOULD NOT BE RETURNED. A REVIEW OF PROGRAMMING HISTORY SHOWED THAT THE PATIENT'S DEVICE WAS DELIVERING THERAPY AT THE (B)(6) 2009 APPOINTMENT. ON (B)(6) 2009, THE PATIENT'S DEVICE WAS INTERROGATED AT SETTINGS TO DELIVER THERAPY. A FAULTED SYSTEM DIAGNOSTIC OCCURRED THAT CHANGED THE PATIENT'S SETTINGS TO 0/20/500/30/60/0/500/30; HOWEVER, AFTER THIS, THE DEVICE WAS PROGRAMMED TO AN OFF TIME OF 5 MINUTES AND LEFT AT AN OUTPUT CURRENT OF 0 MA. TWO SYSTEM DIAGNOSTICS FOLLOWING THIS INDICATED HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 014788

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR