BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 5492197 · Received March 10, 2016

    Report

    Report Number
    1644487-2016-00458
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 10, 2016
    Report Date
    November 3, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    Z0280-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMPANY REPRESENTATIVES PRESENT AT A PATIENT APPOINTMENT HAD PERFORMED TROUBLESHOOTING TO ISOLATE THE CAUSE OF THE INABILITY TO VERIFY HEART BEAT WITH THE PATIENT'S GENERATOR. THE PROCEDURE FOR PRESURGICAL ECG SCREENING WAS PERFORMED, AND IT WAS DETERMINED THAT THE GENERATOR SHOULD BE SET AT DETECTION SENSITIVITY 1. STANDARD TROUBLESHOOTING STEPS TO MINIMIZE COMMUNICATION INTERFERENCE WITH V11.0 SOFTWARE WERE UNSUCCESSFUL. FIELD ACTION TROUBLESHOOTING WITH V9.0 SOFTWARE WAS PERFORMED. AS A PART OF THE TESTING, SYSTEM DIAGNOSTICS WERE REPORTED WITHIN NORMAL LIMITS. THE DEVICE DATA SHOWED AVERAGE DAILY MEASUREMENTS OF 243 NORMAL STIMULATIONS, 53 DETECTIONS, 52 AUTO STIMULATIONS AND 0 AUTOSTIMULATION INHIBITIONS SINCE THE LAST OFFICE VISIT 40 DAYS PRIOR. WITH THE TESTED HEARTBEAT SENSITIVITY SETTINGS OF 1, THE V9.0 PROGRAMMING SOFTWARE SHOWED ACCURATE HEARTBEAT MEASUREMENTS COMPARED TO A REFEREE SYSTEM. REVIEW OF INTERNAL DEVICE DATA SHOWED THAT HEART RATE DETECTION IS SUCCESSFUL DURING DEVICE FUNCTION, AND THE HEART RATE VALUES WERE WITHIN A PHYSIOLOGICAL RANGE. SENSITIVITY SETTINGS ASSOCIATED WITH DEVICE INTERROGATIONS WERE 1, 3, AND 4. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM AN ONGOING IMPLANT SURGERY THAT THERE WERE DIFFICULTIES VERIFYING THE HEARTBEAT DETECTION FEATURE OF THE PATIENT'S INTENDED REPLACEMENT GENERATOR. IT WAS INDICATED THAT PRE-OPERATIVE SCREENING TO DETERMINE ELIGIBILITY WAS NOT COMPLETED. DUE TO PATIENT SIZE, THERE WAS NOT MUCH ABILITY TO MOVE THE GENERATOR AROUND TO IMPROVE DETECTION OF HEART RATE. IT WAS INDICATED THAT SENSITIVITY LEVEL SETTINGS WERE ATTEMPTED WITH NO SUCCESS. TROUBLESHOOTING PROCEDURES WERE FOLLOWED TO RULE OUT COMMUNICATION ISSUES, INCLUDING ENSURING THE TABLET WAS NOT PLUGGED INTO AN AC OUTLET, SECURING THE CABLES, CHECKING OPERATION OF THE WAND BATTERY, AND ENSURING THE WAND WAS ON THE WHOLE TIME THAT WAS DETECTING. INSTRUCTION WAS GIVEN TO ALLOW ENOUGH TIME FOR THE DETECTION ON ALL LEVELS. EACH TIME, THE DETECTION SHOWED "?????" FOR THE REGISTERED BPM. IT ONLY REGISTERED THE HEART RATE ON LEVEL 3 FOR ABOUT 4 SECONDS BEFORE GOING TO "?????". AFTER THESE ATTEMPTS, THE SURGEON DECIDED TO CLOSE THE PATIENT WITH THE GENERATOR IMPLANTED AND END THE SURGERY. REVIEW OF THE GENERATOR DEVICE HISTORY RECORDS FOUND ALL SPECIFICATIONS WERE MET PRIOR TO DISTRIBUTION. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT IN THE CLINIC, HER GENERATOR DISPLAYED 25% BATTERY REMAINING AFTER BEING IMPLANTED ONLY ABOUT A YEAR. THE INTERNAL DEVICE DATA FROM THE PATIENT¿S GENERATOR WAS REVIEWED. ON (B)(6) 2017, THERE WAS NO LOW BATTERY INDICATOR PRESENT WITH BATTERY VOLTAGE RANGING FROM 2.896 ¿ 2.900V. THE CHARGE CONSUMED VALUE ON THIS DATE WAS 14.102%. A 25% REMAINING INDICATOR WAS OBSERVED ON (B)(6) 2017 WITH BATTERY VOLTAGE OF 2.863 ¿ 2.866V AND BATTERY CAPACITY USED OF 20.891%. A 25% REMAINING INDICATOR WAS ALSO OBSERVED ON (B)(6) 2017 WITH BATTERY VOLTAGE AT 2.860V AND BATTERY CAPACITY USED OF 21.350%. AS OF (B)(6) 2017, THE LOWEST BATTERY VOLTAGE REGISTERED WAS 2.843V ON (B)(6) 2017. IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. SURGICAL INTERVENTION HAS NOT OCCURRED TO DATE. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REPLACED PROPHYLACTICALLY. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE SUSPECT PRODUCT WAS REPORTEDLY DISCARDED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149887 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 4410

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR