BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3123822 · Received May 22, 2013

    Report

    Report Number
    1644487-2013-01541
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PHYSICIAN¿S OFFICE REPORTED THAT THE PATIENT WAS REFERRED FOR GENERATOR AND LEAD REPLACEMENT SURGERY DUE TO HIGH IMPEDANCE DETECTED ON SYSTEM DIAGNOSTICS. THERE WAS NO TRAUMA SUSPECTED, AND THE PATIENT IS NOT EXPERIENCING ANY ADVERSE EVENTS. NO X-RAYS WILL BE TAKEN. THE PHYSICIAN MADE THE MEDICAL DECISION TO NOT DISABLE THE GENERATOR, BUT HE UNDERSTANDS THE MANUFACTURER¿S RECOMMENDATION TO DO SO. CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THE PATIENT REMAINED SEIZURE FREE AND HAD NO UNACCEPTABLE SIDE EFFECTS TO VNS STIMULATION. THE GENERATOR WAS INTERROGATED AND PROGRAMMED. DIAGNOSTICS WERE NOT PROVIDED IN THE CLINIC NOTES. ATTEMPTS FOR ADDITIONAL INFORMATION INCLUDING PRODUCT INFORMATION FROM THE IMPLANT HOSPITAL'S RELEASE OF INFORMATION DEPARTMENT HAVE BEEN UNSUCCESSFUL TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. THE MANUFACTURER¿S CLINICAL SPECIALIST ATTENDED THE SURGERY, AND DURING PRE-OPERATIVE DEVICE DIAGNOSTIC TESTING, HIGH LEAD IMPEDANCE WAS RECEIVED. HE REPORTED THAT THE SURGEON WAS NOT AWARE THAT THE PATIENT WAS TO HAVE A GENERATOR AND LEAD REPLACEMENT DUE TO THE HIGH IMPEDANCE, SO ONLY THE GENERATOR WAS REPLACED AT THAT TIME. THE SURGEON BELIEVED THE PATIENT WAS ONLY SCHEDULED FOR A PROPHYLACTIC GENERATOR REPLACEMENT AS THE NEAR END OF SERVICE INDICATOR WAS NOT FLAGGED AND PER THE NEUROLOGIST NOTES. ADDITIONALLY, THERE WERE NO COMPLAINTS OF ANY ADVERSE EVENTS OR PAIN. THE DEVICE WAS STILL TURNED ON AT 1.5 MA. THE IMPLANT CARD WAS RECEIVED AND REPORTED THAT THE GENERATOR WAS REPLACED ON (B)(6) 2013 WITH THE REASON MARKED AS ¿PROPHYLACTIC, LEAD DISCONTINUITY, ADVERSE EVENT - HIGH IMPEDANCE.¿ THE LEAD IMPEDANCE FOLLOWING GENERATOR REPLACEMENT WAS ¿HIGH,¿ AS THE LEAD WAS NOT REPLACED AT THAT TIME. ALTHOUGH LEAD REPLACEMENT MAY OCCUR IN THE FUTURE, IT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT HAD VNS REPLACEMENT SURGERY. THE SURGEON STATED THAT HE SAW WHERE THE LEAD WAS FRACTURED AFTER HE OPENED UP THE PATIENT. THE LEAD WAS BROKEN BY THE COILS. ONE OF THE COILS WAS SHEARED AWAY FROM WHERE THE WIRES STARTS TO COIL. THE SURGEON TOOK OUT THE EXISTING LEAD AND REPLACED IT WITH A NEW ONE. DIAGNOSTICS SHOWED GOOD IMPEDANCE AFTER REPLACEMENT. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225922 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1541

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR