BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 4251636 · Received November 14, 2014

    Report

    Report Number
    1644487-2014-03030
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    February 15, 2018
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT INCLUDE THAT THE MEASURED INSERTION FORCE WAS WITHIN PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL ANALYSIS WAS COMPLETED ON THE RETURNED LEAD AND A REPRESENTATIVE LEAD FOR COMPARISON WHEREBY INSERTION AND WITHDRAWAL FORCES WERE MEASURED USING A FORCE GAUGE. THE AVERAGE INSERTION FORCE OF REPRESENTATIVE LEAD CONNECTOR MEASURED 5.09N. THE AVERAGE INSERTION FORCE OF THE RETURNED LEAD WAS MEASURED 13.1N. DURING TESTING, THE RETURNED LEAD WAS INSERTED AS MUCH AS POSSIBLE TO PREVENT LEAD DAMAGE DUE TO EXCESSIVE FORCE. THE INSERTION ATTEMPTS OF THE RETURNED LEAD RESULTED IN PARTIAL INSERTION OF THE LEAD CONNECTOR WITH THE PIN NOT VISIBLE PAST THE CONNECTOR BLOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VNS IMPLANT SURGERY, THE GENERATOR WAS CONNECTED TO THE LEAD AND SYSTEM DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE. THE LEAD PIN WAS CONFIRMED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK AND THE ELECTRODES WERE CONFIRMED TO BE IMPLANTED CORRECTLY. THE GENERATOR WAS DISCONNECTED FROM THE LEAD AND GENERATOR DIAGNOSTICS WERE PERFORMED WITH A TEST RESISTOR WHICH ALSO SHOWED HIGH IMPEDANCE. A SECOND GENERATOR WAS OPENED AND TESTED WITH THE EXISTING LEAD AND SYSTEM DIAGNOSTICS STILL SHOWED HIGH IMPEDANCE. GENERATOR DIAGNOSTICS WERE PERFORMED ON THE SECOND GENERATOR AND LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS. A SECOND LEAD WAS OPENED TO COMPLETE THE PROCEDURE. THE UNUSED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO OBSTRUCTIONS WERE OBSERVED IN THE HEADER LEAD CAVITY OR CONNECTOR BLOCKS. A BENCH LEAD INSERTED PAST THE CONNECTOR BLOCKS. IN ADDITION, THE IN-LINE CAVITY TEST PASSED. A TORQUE WRENCH AND TEST RESISTOR WAS RETURNED WITH THE UNIT. THE TORQUE WRENCH SECURED THE BENCH SETSCREW AND TEST RESISTOR. THE TEST RESISTOR PASSED THE LOAD RESISTANCE REQUIREMENTS. ANALYSIS OF THE LEAD IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    THE MEASURED 13.1N INSERTION FORCE WAS WITH PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED LEAD WAS COMPLETED. LOCATION OF THE SETSCREW MARKS SUGGEST THAT THE LEAD CONNECTOR WAS NOT INSERTED COMPLETELY AT IMPLANT. ALSO, THE CONNECTOR RING HAS SCRATCHES MOST LIKELY CAUSED BY THE CANTED SPRING IN THE PULSE GENERATOR HEADER DURING INSERTION OF THE LEAD CONNECTOR INDICATING THAT THE LEAD CONNECTOR WAS INSERTED COMPLETELY AT ONE POINT IN TIME. AN ATTEMPT TO INSERT THE DRY LEAD CONNECTOR IN A REPRESENTATIVE PULSE GENERATOR AND IN A PULSE GENERATOR RETURNED WITH THE LEAD SHOW THAT THE LEAD CONNECTOR COULD NOT BE INSERTED COMPLETELY. HOWEVER, THE LEAD CONNECTOR WAS INSERTED COMPLETELY WHEN IT WAS LUBRICATED IN BOTH THE REPRESENTATIVE PULSE GENERATOR HEADER WITH NO ANOMALIES. BASED ON THE PRODUCT ANALYSIS FINDINGS, THERE IS EVIDENCE TO SUGGEST THAT THE LEAD CONNECTOR MAY HAVE EXPERIENCED SOME INSERTION RESISTANCE IN THE PULSE GENERATOR HEADER RESULTING IN AN INCOMPLETE INSERTION. THE REASON FOR THE INSERTION DIFFICULTY IS UNKNOWN. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION WAS LATER INITIATED AND DETERMINED THE CAUSE MAY HAVE BEEN DUE TO THE MANUFACTURING PROCESS. THE MANUFACTURING PROCESS ALLOWED THE USE OF WATER AS LUBRICANT IN THE CASE OF HIGH INSERTION FORCES, WHICH HAD IN FACT BEEN IDENTIFIED IN THE CASE OF THIS LEAD BY COMPARISON TO THE REPRESENTATIVE TEST LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738486 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202987

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR