BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA USA, INC.

    MDR report key: 8634603 · Received May 22, 2019

    Report

    Report Number
    1644487-2019-00997
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 1, 2019
    Report Date
    April 24, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL #1 FOR THIS EVENT WAS SUBMITTED ON TIME ON (B)(6) 2019, BUT CONTAINED THE WRONG MFR REFERENCE #(B)(6) WHEN IT WAS SUPPOSED TO BE (B)(6). THIS REPORT SUBMITTED (B)(6)2024 IS TO CORRECT THE MANUFACTURER REPORT #. ALL OTHER INFORMATION IN THIS REPORT IS IDENTICAL TO THE SUPPLEMENTAL #1 REPORT SUBMITTED ON (B)(6)2019. VOLUNTARY MEDICAL DEVICE CORRECTION (REMEDIAL ACTION) WAS INITIATED BY THE MANUFACTURER ON (B)(6)2018 VIA PHYSICIAN NOTIFICATION LETTER. H7. REMEDIAL ACTION. CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE THAT REMEDIAL ACTION OF A NOTIFICATION WAS SENT REGARDING THE M1000 HIGHER IMPEDANCE REPORTED. H11. ADDITIONAL MANUFACTURER NARRATIVE. CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE THAT A VOLUNTARY MEDICAL DEVICE CORRECTION (REMEDIAL ACTION) WAS INITIATED REGARDING THE M1000

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS DETECTED ON THE PATIENT'S GENERATOR. IT WAS REPORTED BY THE NEUROLOGIST'S OFFICE THAT THE PATIENT HAD NOT EXPERIENCED ANY KNOWN CLINICAL SYMPTOMS TO DATE. THEY ALSO REPORTED THAT THE PATIENT HAD NOT EXPERIENCED ANY KNOWN TRAUMA OR MANIPULATION TO THE GENERATOR OR ELECTRODE SITE. THE REPRESENTATIVE REPORTED THAT THERE WERE WAS NOTHING NOTED ON PATIENT X-RAYS. DEVICE HISTORY RECORDS WERE REVIEWED AND INDICATED THAT THE GENERATOR PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS PRIOR TO DISTRIBUTION. INTERNAL INVESTIGATION IDENTIFIED THAT A CHANGE IN THE TIMING OF THE IMPEDANCE TEST MAY RESULT IN HIGHER IMPEDANCES FOR MODEL 1000 GENERATORS COMPARED TO THOSE REPORTED BY MODEL 103-106 GENERATORS. AS INDICATED IN THE PHYSICIAN'S MANUAL, HIGH LEAD IMPEDANCE (GREATER THAN EQUAL TO 5300 OHMS), IN THE ABSENCE OF OTHER DEVICE RELATED COMPLICATIONS, IS NOT AN INDICATION OF A LEAD OR GENERATOR MALFUNCTION. THE PHYSICIAN ASSESSED THAT THE PATIENT'S HIGH IMPEDANCE WAS RELATED TO THE M1000 GENERATOR HIGHER IMPEDANCE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424846 LIVANOVA USA, INC. GENERATOR LYJ CYBERONICS - HOUSTON 1000 204575 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female