BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3922997 · Received July 9, 2014

    Report

    Report Number
    1644487-2014-01739
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    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

    DATE OF EXPLANT; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE LEAD WAS NOT EXPLANTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RECEIPT OF THE IMPLANT CARD WAS INADVERTENTLY LEFT OFF OF INITIAL MFR. REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT FOR END OF SERVICE, HIGH IMPEDANCE WAS OBSERVED WITH THE NEW GENERATOR AND EXISTING LEAD. THE SURGEON THEN REPLACED THE LEAD. IT WAS REPORTED THAT THE HIGH IMPEDANCE WAS NOT OBSERVED PRIOR TO SURGERY. THE LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS (3459 OHMS) WITH THE NEW GENERATOR AND NEW LEAD. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE IMPLANT CARD ONLY LISTED THE GENERATOR AS BEING REPLACED. THE DECODER SPREADSHEET THAT WAS CREATED DURING GENERATOR PRODUCT ANALYSIS SHOWS THAT THE IMPEDANCE VALUE PRIOR TO EXPLANT ON (B)(6) 2014 WAS 3833 OHMS. IT IS POSSIBLE THAT A HIGH IMPEDANCE MESSAGE WAS SEEN UPON INTERROGATION OF THE IMPLANTED GENERATOR, BUT RESOLVED AFTER COMPLETION OF A SYSTEM DIAGNOSTICS TEST ON THE DAY OF SURGERY. THIS ISSUE WOULD OCCUR WHEN THE GENERATOR IS PROGRAMMED ON FOLLOWING IMPLANT SURGERY WITHOUT FIRST PERFORMING A SYSTEM DIAGNOSTICS TEST TO CLEAR THE STORED IMPEDANCE VALUE FROM FET. ATTEMPTS TO CONFIRM WHETHER OR NOT THE LEAD WAS REPLACED DURING GENERATOR REPLACEMENT SURGERY HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S LEAD WAS NOT REPLACED DURING THE PROCEDURE ON (B)(6) 2014. THE REPLACEMENT GENERATOR WAS TESTED WITH THE EXISTING LEAD AND DIAGNOSTIC RESULTS SHOWED LEAD IMPEDANCE WITHIN NORMAL LIMITS (IMPEDANCE VALUE - 3459 OHMS). THE PATIENT¿S REPLACEMENT DEVICE WAS PROGRAMMED BACK ON PREVIOUS DEVICE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399388 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR