BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3823857 · Received May 21, 2014

    Report

    Report Number
    1644487-2014-01321
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS AND AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S GENERATOR COULD NOT BE INTERROGATED DURING AN OFFICE VISIT ON (B)(6) 2014. TWO PROGRAMMING SYSTEMS WERE USED AND BOTH WERE UNSUCCESSFUL IN COMMUNICATING WITH THE PATIENT¿S DEVICE. THE WAND BATTERY WAS REPLACED BUT THE COMMUNICATION ISSUES WERE NOT RESOLVED. THE PROGRAMMING SYSTEMS WERE ABLE TO COMMUNICATE WITH OTHER PATIENTS¿ DEVICES WITHOUT ANY ISSUES. THE PATIENT HAD A FOLLOW-UP APPOINTMENT FIVE DAYS LATER AND THE PATIENT¿S DEVICE STILL HAD COMMUNICATION ISSUES. THE LAST DIAGNOSTIC TEST WAS PERFORMED ON (B)(6) 2013 AND SHOWED NO LOW BATTERY INDICATOR. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 0.28 YEARS UNTIL ERI = YES. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE. AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE GENERATOR REPLACEMENT SURGERY WAS DUE TO BATTERY DEPLETION; HOWEVER, THE NEUROLOGIST STATED THAT THE FAILURE TO INTERROGATE WAS DUE TO BATTERY DEPLETION OR A DEVICE MALFUNCTION. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY REVEALED APPROXIMATELY 0.28 YEARS UNTIL ERI = YES.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RECEIVED FOR ANALYSIS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON 08/26/2014. ANALYSIS IN THE PA LAB DETERMINED THAT THE DEVICE¿S FAILURE TO PROGRAM WAS RELATED TO AN END OF SERVICE CONDITION; AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE CONFIRMED THAT THE BATTERY WAS DEPLETED. BASED ON THE BENCH ANALYSIS AND THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT WERE WITHIN SPECIFICATION; THEREBY, DEMONSTRATING NORMAL BATTERY DEPLETION TO AN END OF SERVICE CONDITION. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THEREFORE, THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PA LAB, WILL BE USED TO CONCLUDE THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302592 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200768

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR