BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3232393 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02160
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    March 1, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY DID NOT INDICATE ANY ANOMALIES. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASS ALL FUNCTIONAL TESTS 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

    ON (B)(6) 2013 INFORMATION WAS RECEIVED FROM THE REPORTER THAT THE PHYSICIAN WAS HAVING DIFFICULTIES PROGRAMMING THE PATIENT¿S VNS SYSTEM. THE PHYSICIAN HAD SEEN THE PATIENT 6 WEEKS PRIOR TO THIS EVENT, IN (B)(6) 2013, AND HAD EXPERIENCED THE SAME DIFFICULTY. THE PHYSICIAN SUSPECTED THAT THE GENERATOR MIGHT BE AT END OF SERVICE. THE SURGEON DETERMINED THAT THE PATIENT COULD FEEL THAT THE VNS SYSTEM WAS ON, SO THE SURGEON DID NOT RECOMMEND A GENERATOR REPLACEMENT AT THE TIME. A REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY WAS PERFORMED, SHOWING THAT DATA WAS AVAILABLE FROM THE IMPLANT DATE OF IMPLANT ON 05/13/2010 THROUGH THE PRESENT. THE GENERATOR WAS LAST ON A 16% DUTY CYCLE. THE LAST DIAGNOSTICS TEST PERFORMED WAS A SYSTEM DIAGNOSTICS TEST ON (B)(6) 2012, SHOWING THAT ALL SYSTEMS WERE FINE AND THAT THE GENERATOR WAS NOT NEAR END OF SERVICE. A BATTERY LIFE CALCULATION PERFORMED BASED ON THE AVAILABLE DATA AND KNOWN SETTINGS ALSO SHOWED THAT THE GENERATOR WAS NOT NEAR END OF SERVICE. NO ANOMALIES WERE OBSERVED DURING THE REVIEW OF THE PROGRAMMING HISTORY. DEVICE MANUFACTURING RECORDS WERE REVIEWED FOR THE GENERATOR AND THEY HAVE CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN CONTINUATION.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT¿S DEVICE WAS UNABLE TO BE INTERROGATED DURING AN OFFICE VISIT ON (B)(6) 2014. THE PATIENT MENTIONED THAT THE FAILURE TO PROGRAM HAS HAPPENED BEFORE. THE PATIENT RETURNED TO THE OFFICE ON (B)(6) 2015 AND THE DEVICE WAS SUCCESSFULLY INTERROGATED.

    Description of Event or Problem · 1

    FOLLOW UP FOUND THAT THE PATIENT'S DEVICE WAS ABLE TO BE INTERROGATED WITH A DIFFERENT PROGRAMMING WAND. THE PHYSICIAN WAS STILL UNABLE TO INTERROGATE THE PATIENT'S DEVICE WITH HIS WAND; HOWEVER, IT WAS BELIEVED THAT THIS MAY BE DUE TO THE DEPTH OF THE IMPLANT IN THE PATIENT OR THE ANGLE. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE WAND PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. ADDITIONAL FOLLOW UP AGAIN CONFIRMED THE PATIENT'S DEVICE WAS ABLE TO BE INTERROGATED WITH AND ALL SYSTEMS CHECKS WERE NORMAL. THE PHYSICIAN AND NURSE WERE PROVIDED INFORMATION ON INTERROGATING THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333841 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 201274

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR