BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3202882 · Received July 2, 2013

    Report

    Report Number
    1644487-2013-02023
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 28, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF THE LEAD MANUFACTURING HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT¿S DEVICE WAS TURNED OFF ON (B)(6) 2013. NO TRAUMA OR MANIPULATION WAS REPORTED TO HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. IN THE PHYSICIAN¿S OPINION, THERE IS NOTHING NOTED BETWEEN THE RELATIONSHIP OF THE PATIENT¿S INCREASE IN SEIZURES RELATION TO VNS. THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013. THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED BY THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(4) 2013. HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    THE LEAD ANALYSIS WAS COMPLETED ON (B)(4) 2013. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. THE GENERATOR ANALYSIS WAS COMPLETED ON (B)(4) 2013. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS DETECTED ON THE PATIENT¿S VNS SYSTEM UPON PERFORMING DIAGNOSTICS AT AN OFFICE VISIT. NO TRAUMA WAS REPORTED. X-RAYS WERE TAKEN AND REVIEWED BY THE MEDICAL PROFESSIONAL(S); NO GROSS LEAD FRACTURES WERE REPORTEDLY OBSERVED. THE PATIENT WAS REFERRED FOR VNS REPLACEMENT SURGERY. THE FACESHEET RECEIVED FOR REFERRAL FOR SURGERY INDICATED THAT THE PATIENT HAD AN ED VISIT ON (B)(6) 2013 CLINIC NOTES DATED (B)(6) 2013 REPORTED THAT THE PATIENT HAS HAD EPISODES OF STATUS EPILEPTICUS AND ALSO HAS HAD FREQUENT BREAKTHROUGH SEIZURES. RECENTLY, SHE DEVELOPED INCREASED SEIZURE FREQUENCY, INCREASINGLY INTRACTABLE AND WAS ACCOMPANIED WITH INCREASED STUTTERING. THE PATIENTS SEIZURES HAD BEEN MARKEDLY IMPROVED. ¿VNS DID SEEM TO BE OF SOME BENEFIT.¿ HIGH LEAD IMPEDANCE WAS OBSERVED ON THIS DATE, ¿SUGGESTING THE POSSIBILITY OF LEAD MALFUNCTION.¿ THE PATIENT¿S EPILEPSY HAD BEEN VERY WELL CONTROLLED. THE PATIENT DID NOT APPEAR TO BE HAVING SIGNIFICANT SIDE EFFECTS. PA/AP AND CERVICAL SPINE X-RAYS WERE REQUESTED. NO VNS PROGRAMMING CHANGES WERE MADE. PREVIOUSLY ON (B)(6) 2013, AN ANTI-SEIZURE MEDICATION WAS TAPERED DUE TO BEHAVIOR DIFFICULTIES. THE PHYSICIAN RECOMMENDED INCREASING THIS MEDICATION AGAIN ON (B)(6) 2013. THE LAST AVAILABLE DIAGNOSTICS IN THE MANUFACTURER¿S DATABASE SHOW THAT THE SYSTEM WAS FUNCTIONING PROPERLY AS LAST CHECKED ON (B)(6) 2012. AP CHEST, AP NECK, AND LATERAL CHEST IMAGES WERE PROVIDED TO THE MANUFACTURER FOR REVIEW. NO GROSS FRACTURES, LEAD DISCONTINUITIES, OR SHARP ANGLES ARE NOTED IN THE VISIBLE LEAD PORTION. LEAD DOES APPEAR TO BE PRESENT BEHIND THE GENERATOR AND THEREFORE, CANNOT BE ASSESSED. BASED ON THE LIMITED QUALITY OF THE IMAGES AVAILABLE, A CAUSE FOR THE HIGH IMPEDANCE CANNOT BE DETERMINED. THE PRESENCE OF A MICROFRACTURE OR A DISCONTINUITY IN THE LEAD PORTION NOT VISIBLE CANNOT BE RULED OUT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302678 LEAD MODEL 302 LEAD LYJ LIVANOVA USA, INC. 302-20 201117

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Required Intervention