BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3023688 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00837
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT THIS WAS LIKELY DUE TO USER ERROR; THIS DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. EXAMINATION OF THE SET SCREW SHOWED THERE WAS DAMAGE TO THE HEX HEAD. THIS COULD BE AN INDICATION THAT THE SHAFT OF THE TORQUE WRENCH WAS NOT FULLY ENGAGED INTO THE HEX HEAD WHICH WOULD PREVENT THE TIGHTENING OF THE SETSCREW ON THE LEAD PIN OR THE TEST RESISTOR. THE DAMAGE TO THE HEX HEAD COULD ALSO MAKE IT DIFFICULT TO LOOSEN THE SETSCREW AND REMOVE THE LEAD PIN. DIAGNOSTIC TEST RESULTS DEMONSTRATED THAT THE 4K OHM ELECTRICAL LOAD RESISTANCE (TEST RESISTOR) IS ACCURATELY MEASURED BY THE PULSE GENERATOR WITH NO NOTED ADVERSE PERFORMANCE. PRODUCT ANALYSIS CONFIRMED STRIPPED SETSCREW SOCKET THAT WAS MOST LIKELY CAUSED BY INCOMPLETE INSERTION OF THE TORQUE WRENCH SHAFT INTO THE SOCKET OF THE SCREW; MOST LIKELY USER RELATED ISSUE; NO DEVICE MALFUNCTION WAS OBSERVED. PRODUCT ANALYSIS OF THE HEX SCREWDRIVERS CONFIRMED ROUNDED EDGES ON END OF SHAFT. PRODUCT ANALYSIS STATED THAT THIS WAS DUE TO INCOMPLETE INSERTION INTO SETSCREW; USER-RELATED ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A FULL REVISION SURGERY. THE PATIENT WAS IMPLANTED WITH A NEW LEAD AND GENERATOR BUT WHEN THE NEW LEAD WAS CONNECTED TO THE NEW GENERATOR, THE SYSTEM DIAGNOSTICS TEST SHOWED HIGH LEAD IMPEDANCE WITH AN IMPEDANCE VALUE GREATER THAN 10,000OHMS. THE SURGEON THEN REMOVED THE NECK RETRACTORS AND BOVIE CORDS FROM THE SITE. THE NEXT SYSTEM DIAGNOSTICS ALSO SHOWED HIGH LEAD IMPEDANCE WITH AN IMPEDANCE VALUE GREATER THAN 10,000 OHMS. THE SURGEON THEN CHECKED THE ELECTRODES AND SAID IT LOOKED LIKE ONE WAS NOT ON PROPERLY AND RE-POSITIONED THE ELECTRODE. THE MANUFACTURER'S CONSULTANT CONFIRMED THAT THE ELECTRODE PLACEMENT APPEARED NORMAL. THE NEXT SYSTEM DIAGNOSTICS STILL SHOWED HIGH LEAD IMPEDANCE. THE SURGEON RE-VERIFIED THAT THE ELECTRODES WERE ON PROPERLY. THE SCRUB NURSE NOTED TO THE SURGEON THAT THE LEAD PIN WAS NOT FULLY INSERTED PAST THE CONNECTOR BLOCK. THE SURGEON REMOVED THE LEAD PIN AND RE-INSERTED IT. THE NEXT SYSTEM DIAGNOSTICS TEST STILL SHOWED HIGH IMPEDANCE. THE SURGEON NOTED THAT THE PIN WAS STILL NOT PAST THE CONNECTOR BLOCK AND THEREFORE HE REMOVED THE PIN AND REINSERTED IT. UPON THIS SECOND PIN INSERTION HE MADE SURE THE PIN WAS VISUALIZED PAST THE CONNECTOR BLOCK, BUT THERE WAS NO AUDIBLE CLICK WHEN HE TRIED TO TIGHTEN THE SET SCREW AND THE SCREWDRIVER JUST KEPT SPINNING IN PLACE AND 'WOULD NOT CATCH.' THE MANUFACTURER'S CONSULTANT THEN OBTAINED A DIFFERENT GENERATOR TO BE USED. AFTER THE SECOND NEW GENERATOR WAS CONNECTED TO THE LEAD, HIGH IMPEDANCE WAS AGAIN OBSERVED BUT THE LEAD PIN WAS NOT FULLY INSERTED. THE PIN WAS REINSERTED INTO THE GENERATOR AND THE LEAD PIN WAS VERIFIED TO BE PAST THE CONNECTOR BLOCK. THERE WAS A LOUD AUDIBLE CLICK. A SYSTEM DIAGNOSTICS TEST WAS PERFORMED AND REVEALED RESULTS WITHIN NORMAL LIMITS; NO HIGH LEAD IMPEDANCE WAS OBSERVED. OTHER DIAGNOSTICS WERE PERFORMED AND WERE ALSO WITHIN NORMAL LIMITS. THE MANUFACTURER'S CONSULTANT LATER CLARIFIED THAT THEY DID HEAR THE SETSCREW CLICK THE FIRST TIME THE TORQUE WRENCH WAS USED TO TIGHTEN THE SETSCREW DOWN WITH THE NEW GENERATOR AND OLD LEAD AND THEY HEARD THE SETSCREW CLICK THE FIRST TIME THE TORQUE WRENCH WAS USED TO TIGHTEN THE SETSCREW DOWN WITH THE NEW GENERATOR AND NEW LEAD. BUT UPON SECOND PIN RE-INSERTION, THERE WAS NO CLICK NOISE AND THE SCREWDRIVER JUST SPUN AROUND. THE GENERATOR AND TWO HEX SCREWDRIVERS WERE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(4) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED. THE MANUFACTURING RECORDS FOR THE GENERATOR WERE REVIEWED; THE DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126970 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202238

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR