BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3200424 · Received July 1, 2013

    Report

    Report Number
    1644487-2013-01963
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    January 1, 2007
    Report Date
    June 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT THIS PATIENT¿S GENERATOR WAS EXPLANTED BECAUSE IT MADE HER SEIZURES WORSE. THE PATIENT HAS COMPLEX PARTIAL SEIZURES WITH OCCASIONAL SECONDARY GENERALIZATION. THE PATIENT¿S SEIZURES INCREASED WHEN THE OUTPUT CURRENT WAS INCREASED TO 0.5 MA IN (B)(6) 2007. THE PATIENT¿S SETTINGS WERE REDUCED TO 0.25 MA OUTPUT CURRENT IN (B)(6) 2007 AND INCREASED TO 0.5 MA OUTPUT CURRENT IN (B)(6) 2007. THE DEVICE WAS DISABLED IN (B)(6) 2008 AT THE PATIENT¿S REQUEST. THE DEVICE REMAINED OFF UNTIL EXPLANT. REVIEW OF PROGRAMMING HISTORY SHOWS THAT THE PATIENT¿S DEVICE WAS DISABLED ON (B)(6) 2008.

    Description of Event or Problem · 1

    THE GENERATOR AND LEAD WERE RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(6) 2013. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. THE LEAD ANALYSIS WAS COMPLETED ON (B)(4) 2013. NOTE THAT THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED EXCEPT FOR THE SETSCREW MARKS OBSERVED NEAR THE END OF THE CONNECTOR PIN, INDICATING THE CONNECTOR PIN HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE PULSE GENERATOR AT ONE TIME. BASED ON THE LOCATION OF THE SETSCREW MARKS ON THE PIN, IT IS UNKNOWN WHETHER A GOOD ELECTRICAL CONNECTION WAS PRESENT FOR THE CONNECTOR RING. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299121 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014628

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention