BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3152434 · Received June 7, 2013

    Report

    Report Number
    1644487-2013-01711
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS PERFORMED. REVIEW OF THE GENERATOR DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013 ADDITIONAL PROGRAMMING HISTORY WAS REVIEWED. REVIEW OF THE DATA SHOWS THAT NO DIAGNOSTICS WERE PERFORMED ON THE DATE OF SURGERY. THE GENERATOR ON THE IMPLANT DATE WAS OFF. THEN, THE DEVICE WAS PROGRAMMED ON FOLLOWED BY AN INTERROGATION AFTER. THE DIAGVINITIAL VALUE IS 51631 OHMS THAT SHOWS UP AS LEAD IMPEDANCE VALUE ON THE DECODER IS A STORED VALUE IN THE GENERATOR. THIS VALUE IS NOT A SET VALUE; IN MANUFACTURING, THIS VALUE COULD BE ANY VALUE. SO THE FIRST TIME THE GENERATOR IS INTERROGATED, IT WILL NOT SHOW AS HIGH IMPEDANCE MESSAGE, BUT THE FACT THAT THEY PROGRAMMED IT ON AFTER THAT AND THEN RAN INTERROGATION, IT PULLED THE INITIAL HIGH IMPEDANCE UPON PERFORMING THE FIRST DIAGNOSTIC TEST AFTER THIS SEQUENCE OF EVENTS. THE TEST RESISTOR WAS RECEIVED WITHIN THE GENERATOR. THE DIAGVINITIAL 4094 OHMS = IMPEDANCE VALUE ON THE AS-RECEIVED DECODER IN PRODUCT ANALYSIS WHICH IS NORMAL BECAUSE THE TEST RESISTOR WAS LEFT WITHIN THE GENERATOR, AND THE GENERATOR WAS PROGRAMMED ON. THE M105 GENERATOR PERFORMS 24 HOUR MEASUREMENTS WHICH IS WHY THE GENERATOR WAS RECEIVED WITH DIAGNOSTICS WITHIN NORMAL LIMITS WHICH IS EXPECTED BEHAVIOR. IN THIS INSTANCE, THE IMPEDANCE VALUE NEVER GOT REPLACED BECAUSE DIAGNOSTICS WERE NOT PERFORMED.

    Description of Event or Problem · 1

    ANALYSIS WAS COMPLETED ON THE GENERATOR. THE REPORTED HIGH IMPEDANCE WAS NOT DUPLICATED IN THE LAB. RESULTS OF DIAGNOSTIC TESTS INDICATED THE DEVICE OPERATED AND COMMUNICATED PROPERLY. THESE RESULTS ALSO DEMONSTRATED THE GENERATOR'S ABILITY TO ACCURATELY MEASURE A NUMBER OF DIFFERENT RESISTANCE LOADS. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Description of Event or Problem · 1

    A VNS NEUROSURGEON REPORTED THAT HIGH IMPEDANCE WAS PRESENT ON A NEW MODEL 105 GENERATOR HE HAD JUST CONNECTED TO THE LEAD DURING A PATIENT¿S GENERATOR REPLACEMENT SURGERY. HE REPORTED THAT THE LEAD PIN APPEARED TO BE PAST THE CONNECTOR BLOCK, AND HE HAD TIGHTENED THE HEX SCREW. THE LEAD PIN WAS RE-INSERTED AGAIN, BUT HIGH IMPEDANCE STILL RESULTED. THE GENERATOR WAS THEN DISCONNECTED FROM THE LEAD, AND GENERATOR DIAGNOSTICS WERE PERFORMED WITH A TEST RESISTOR TIGHTENED INTO THE GENERATOR, BUT HIGH IMPEDANCE STILL RESULTED. THE SURGEON ELECTED TO IMPLANT ANOTHER MODEL 105 GENERATOR AS HE FELT THE OTHER MODEL 105 GENERATOR WAS DEFECTIVE. UPON IMPLANTING AND CONNECTING THE NEW REPLACEMENT MODEL 105 GENERATOR, DIAGNOSTICS WERE ALL OKAY WITH IMPEDANCE VALUE OF 1601 OHMS. THE UNUSED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252727 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3444

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR