BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 9097830 · Received September 20, 2019

    Report

    Report Number
    1644487-2019-01827
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    July 17, 2015
    Report Date
    October 15, 2019
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LEFT OUT INFORMATION REGARDING THE REVIEW OF THE DEVICE HISTORY RECORDS AND CONFIRMATION OF LASER ROUTING. (B)(4).

    Description of Event or Problem · 1

    A REVIEW OF DEVICE HISTORY RECORDS REVEALED THAT THE GENERATOR PASSED QUALITY CONTROL INSPECTION PRIOR TO DISTRIBUTION. PER THE PRODUCT ANALYSIS, THE DEVICE WAS CONFIRMED AS LASER ROUTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT VNS GENERATOR REPLACEMENT SURGERY DUE TO BATTERY DEPLETION. THE EXPLANTED GENERATOR WAS RECEIVED BY THE MANUFACTURER. GENERATOR PRODUCT ANALYSIS WAS COMPLETED. THE REPORTED END OF SERVICE, OR EOS, CONDITION WAS DUPLICATED IN THE PRODUCT ANALYSIS, OR PA, LAB. DURING INTERROGATION, THE PULSE DISABLED AND EOS WARNINGS WERE SET. THE PULSE DISABLED BYTE WOULD NOT RESET AND, THEREFORE, SYSTEM DIAGNOSTICS AND THE FET COULD NOT BE PERFORMED. THE DATA IN THE DIAGACCUM CONSUMED MEMORY LOCATIONS REVEALED THAT 52.606% OF THE BATTERY HAD BEEN CONSUMED. WITH THE CASE REMOVED AND THE BATTERY STILL ATTACHED TO THE PRINTED CIRCUIT BOARD ASSEMBLY, OR PCBA, THE BATTERY MEASURED 1.824 V, CONFIRMING THE EOS CONDITION. CONTAMINATES WERE OBSERVED ON THE TRIMMED EDGE OF THE PCBA. THE BATTERY WAS REMOVED AND THE PCBA WAS SUBJECTED TO A POSTBURN ELECTRICAL TEST AND FAILED SEVERAL TESTS. WITH THE REMOVAL OF THE OBSERVED CONTAMINATES, THE RESULTS OF THE POSTBURN ELECTRICAL TEST WERE AS EXPECTED. THE OBSERVED CONTAMINATION SUGGESTED PROBABLE ELECTRICAL PATHS WERE ESTABLISHED BETWEEN THE COPPER EDGES ON THE TRIMMED EDGE OF THE PCBA, WHICH CONTRIBUTED TO THE SUPPLY CURRENT CONDITIONS AND RESULTED IN INCREASED OUT OF SPECIFICATION CURRENT CONSUMPTION FOR BOTH STANDBY AND PULSING MODES. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REPORTED EOS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894342 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 203424 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR