BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2964079 · Received February 15, 2013

    Report

    Report Number
    1644487-2013-00418
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR PRIOR TO DISTRIBUTION. 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 THAT THE PATIENT HAD HIGH IMPEDANCE AND WAS BEING REFERRED FOR A FULL REVISION. IT WAS UNKNOWN IF THE PATIENT HAS HAD ANY RECENT TRAUMA OR DEVICE MANIPULATION. THE PATIENT HAD X-RAYS TAKEN BUT THEY WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW. THERE WAS REPORTED NOTHING WAS SEEN ON THE X-RAYS PER THE SURGEON'S OFFICE. LAST GOOD DIAGNOSTICS WERE ON (B)(6) 2012 AND THERE WERE NO ERI FLAGS WERE OBSERVED. THE PATIENT HAD THEIR GENERATOR AND LEAD REPLACED HOWEVER ONLY THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PA LAB. THE BATTERY VOLTAGE WAS 2.918 VOLTS, (NOT AT IFI) AS MEASURED. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 68.497% OF THE BATTERY HAD BEEN CONSUMED. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68408 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 7519

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR