BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2972964 · Received February 21, 2013

    Report

    Report Number
    1644487-2013-00475
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. EVENT DESCRIPTION, CORRECTED DATA: SUPPLEMENTAL REPORT #1 INADVERTENTLY LEFT OFF THE INFORMATION FROM THE RETURNED PRODUCT FORM.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF REPORT 2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR REVISION SURGERY DUE TO HIGH IMPEDANCE AND AN INCREASE IN SEIZURES. CLINIC NOTES REVEALED THAT THE INCREASE IN SEIZURES BEGAN IN (B)(6) 2012. THE HIGH IMPEDANCE READING WAS OBTAINED (B)(6) 2013. IT IS UNKNOWN WHETHER OR NOT THE INCREASE IN SEIZURES IS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY AND WHETHER OR NOT THE PHYSICIAN ATTRIBUTES THE INCREASE IN SEIZURES TO A LOSS IN THERAPY RELATED TO THE HIGH IMPEDANCE READING. THE PHYSICIAN DICTATED IN THE CLINIC NOTES FROM (B)(6) 2013 THAT THE WORSENED SEIZURES HAVE AN UNCLEAR CAUSE. THE PATIENT WAS WEANED OFF AN ANTI-SEIZURE MEDICATION IN (B)(6) 2012 WITHOUT WORSENING SEIZURES. NO MEDICATION CHANGES WERE MADE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE NEUROLOGIST INDICATED THAT THERE WAS NO MANIPULATION OR TRAUMA THAT OCCURRED THAT COULD HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. THE NEUROLOGIST ALSO REPORTED THAT THE BELIEVE CAUSE OF THE INCREASE IN SEIZURES IS RELATED TO THE LOSS OF THERAPY DUE TO THE HIGH IMPEDANCE. THERE WERE NO OTHER CONTRIBUTING FACTORS KNOWN THAT COULD HAVE ATTRIBUTED TO THE INCREASE IN SEIZURES. THE NEUROLOGIST DID NOT PROGRAM THE GENERATOR OFF AFTER IDENTIFYING THE HIGH IMPEDANCE READING. THE NEUROLOGIST WAS UNSURE WHETHER THE INCREASE IN SEIZURES WAS ABOVE THE PATIENT'S PRE-VNS BASELINE AS THE PATIENT WAS TRANSFERRED TO HIS CARING AFTER IMPLANTATION. THE NEUROLOGIST INDICATED THAT BOTH TYPES OF SEIZURES HAD INCREASED FOR THE PATIENT. THE IMPLANT CARD WAS RECEIVED WHICH VERIFIED BOTH LEAD AND GENERATOR WERE EXPLANTED ON (B)(6) 2013. THE REASON WAS NOT INDICATED AND THE LEAD IMPEDANCE WAS NOT CHECKED. BOTH GENERATOR AND LEAD HAVE BEEN RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    THE NEUROLOGIST INDICATED THAT THE DENSE SCLEROSIS FOUND AT EXPLANT LIKELY CAUSED THE PATIENT'S INCREASE IN SEIZURES. THE NEUROLOGIST ALSO INDICATED THAT HE BELIEVES THE DEVICE WAS NOT WORKING WELL DUE TO THE DENSE SCLEROSIS.

    Description of Event or Problem · 1

    A LEAD FRACTURE IS THE MOST LIKELY CAUSE OF THE HIGH IMPEDANCE.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(6) 2013. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE LEAD WAS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. ANALYSIS OF THE PULSE GENERATOR WAS COMPLETED ON (B)(6) 2013. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING THE FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE RETURNED PRODUCT FORM CONFIRMED THAT THE LEAD AND GENERATOR WERE EXPLANTED ON (B)(6) 2013 DUE TO DENSE SCLEROSIS AT ELECTRODES, PRODUCT NOT WORKING WELL AND LYMPHADENOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76667 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 201680

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other| R