BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4033637 · Received August 25, 2014

    Report

    Report Number
    1644487-2014-02092
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    March 6, 2014
    Report Date
    May 18, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT A FEW MONTHS AGO AND WHEN THE PATIENT WAS SEEN THAT DAY, DIAGNOSTICS SHOWED HIGH IMPEDANCE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SURGERY. DURING THE SURGERY, THE SURGEON WAS UNABLE TO COMPLETE THE LEAD REPLACEMENT DUE TO FINDING SCAR TISSUE AND FIBROSIS IN THE NECK COVERING THE EXISTING LEAD ELECTRODES AS WELL AS THE VAGUS NERVE. OUT OF SAFETY CONCERNS FOR THE PATIENT, THE SURGEON ELECTED TO END THE PROCEDURE WITHOUT REPLACING THE LEAD. THE PATIENT'S HUSBAND THEN DECIDED AGAINST GENERATOR REPLACEMENT. THE PREEXISTING GENERATOR AND LEAD WERE LEFT IMPLANTED. THE PATIENT WAS UNSURE IF THE GENERATOR WAS LEFT PROGRAMMED OFF AND DESIRES FINDING A NEW SURGEON WHO MAY BE ABLE TO ACCOMPLISH LEAD REPLACEMENT.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 WERE RECEIVED WHICH INDICATED ¿VNS APPEARS NON-FUNCTIONING¿. CLINIC NOTES DATED (B)(6) 2014 INDICATED THAT THE VNS INTERROGATION APPEARS TO BE WORKING BUT THE PATIENT REPORTS NO SENSATION ¿ NO VOICE CHANGES WERE NOTED. CLINIC NOTES DATED (B)(6) 2014 INDICATE THAT THE PATIENT IS STILL HAVING NO PHYSICAL SENSATION FROM VNS. THE PATIENT¿S SETTINGS WERE INCREASED. CLINIC NOTES DATED (B)(6) 2014 AGAIN REPORTS THAT THE PATIENT CAN¿T FEEL THE VNS GOING OFF AND THAT THE PATIENT IS DEPRESSED. CLINIC NOTES DATED (B)(6) 2014 INDICATE THAT DIAGNOSTICS TEST SHOWED HIGH LEAD IMPEDANCE AND OUTPUT STATUS OF LIMIT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS STILL SEARCHING FOR A SURGEON TO HAVE A VNS FULL REVISION SURGERY AS THE PATIENT STILL HAS BEEN EXPERIENCING AN INCREASE IN DEPRESSION. PER THE PHYSICIAN THE INCREASED DEPRESSION IS ABOVE PRE-VNS BASELINE LEVELS NOW AND IS DUE TO THE LOSS OF VNS THERAPY DUE TO HIGH IMPEDANCE. THE PHYSICIAN NOTED THAT THE VNS WAS DISABLED FOLLOWING THE IDENTIFICATION OF THE HIGH IMPEDANCE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514008 LEAD MODEL 302 LEAD MUZ LIVANOVA USA, INC. 302-20 1556

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR