BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3040354 · Received April 8, 2013

    Report

    Report Number
    1644487-2013-00949
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING IMPLANT SURGERY ON (B)(6) 2013, A PHYSICIAN DISCONNECTED THE LEAD AND GENERATOR IN ORDER TO TUNNEL LEAD. EVEN WITH SEVERAL ATTEMPTS TO UNLOCK THE SCREW (VISIBLE VIA DOME OF SILICON PLUG IN GENERATOR BLOCK) HE WAS FINALLY NOT ABLE TO DISCONNECT. 'POWER' WAS USED WHICH DISRUPTED THE LEAD: THE GENERATOR WAS STILL CONNECTED TO THE LEAD. THE LEAD AND GENERATOR WERE BOTH EXPLANTED, AND A BACK-UP SYSTEM WAS IMPLANTED. CLARIFICATION WAS RECEIVED THAT SEVERAL ATTEMPTS TO UNSCREW WERE MADE, AND SCREWDRIVER WORKED WELL. UPON DISCONNECTION OF THE GENERATOR WITH THE LEAD, A SMALL DISCONNECT FIELD WAS SEEN IN THE CONNECTION POINT; THEREFORE A NEW GENERATOR AND LEAD WERE IMPLANTED. THE SURGEON COULD ALREADY SEE THE SILICON SEAL COME UP (DOME). THE LEAD AND GENERATOR WERE RETURNED ON (B)(6) 2013 AND ARE PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ANALYSIS OF THE VNS GENERATOR AND LEAD WAS COMPLETED. NO OBSTRUCTIONS WERE OBSERVED IN THE GENERATOR HEADER LEAD CAVITY OR CONNECTOR BLOCKS OF THE PULSE GENERATOR. IN ADDITION, THE IN-LINE CAVITY GO GAUGE TEST, DESIGNED TO VERIFY PROPER LEAD CAVITY DIMENSIONS IN THE HEADER AREA, PASSED. A BENCH LEAD INSERTED COMPLETELY PAST THE NEGATIVE CONNECTOR BLOCK AND WAS SET/RELEASED WITH THE RETURNED SETSCREW (LAB CONDITIONS). THE BENCH TEST LEAD REMOVED FROM THE PULSE GENERATOR HEADER WITH NO DIFFICULTIES (LAB CONDITIONS). IN ADDITION, THE AS RECEIVED PHOTOS (PRIOR TO DECONTAMINATION) OF THE RETURNED PULSE GENERATOR AND LEAD SHOW THAT THE SETSCREW IS IN THE DOWN POSITION (SET), WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REMOVAL DIFFICULTIES. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE GENERATOR WAS STILL CONNECTED TO THE LEAD. DOCUMENTED ¿AS-RECEIVED¿ CONDITION PROVIDED BY THE DECONTAMINATION TECHNICIAN NOTES THAT THE GENERATOR SETSCREW WAS TIGHTENED ONTO THE LEAD CONNECTOR PIN. DURING THE VISUAL ANALYSIS THE CONNECTOR BOOT / INNER SILICONE TUBES APPEARED TO BE TORN IN HALF AT THE END OF THE CONNECTOR RING WITH THE QUADFILAR COILS STRETCHED AND KINKED IN BETWEEN THE TWO HALVES. THE (+) WHITE AND (-) GREEN ELECTRODE RIBBONS APPEARED TO BE STRETCHED AND THE HELICES MISSHAPED; INDICATING THE LEAD ASSEMBLY HAD BEEN ATTEMPTED TO BE USED. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED ON THE RIBBONS AND HELICES. WITH THE EXCEPTION OF THE DAMAGED CONNECTOR BOOT, THE CONDITION OF THE RETURNED LEAD ASSEMBLY IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN ATTEMPTED IMPLANT PROCEDURE. THE RESISTANCE MEASUREMENTS TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD ASSEMBLY WERE PERFORMED WITH NO DISCONTINUITIES IDENTIFIED. NO COIL BREAKS WERE FOUND. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST ANY DEVICE-RELATED ANOMALY WITH THE RETURNED LEAD. THE TIGHTENED SETSCREW MAY HAVE CONTRIBUTED TO THE DAMAGED CONNECTOR BOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142938 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 3312

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR