BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3090585 · Received May 2, 2013

    Report

    Report Number
    1644487-2013-01223
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    November 24, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE LEAD AND GENERATOR CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4)..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE. IT WAS REPORTED THAT THE PATIENT DOES NOT HAVE ANY COMPLAINTS AT THIS TIME AND FEELS THAT VNS HAS HELPED HER DEPRESSION AND WOULD LIKE TO HAVE HER DEVICE REPLACED PRIOR TO BATTERY DEPLETION. IT WAS REPORTED THAT IF THE PATIENT'S INSURANCE DOES NOT COVER THE SURGERY THEN THE SURGEON WILL NOT BE ABLE TO REPLACE HER SYSTEM. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT PROGRAMMED OFF BECAUSE THE PATIENT WANTS TO CONTINUE THERAPY. THE SURGEON BELIEVED THE HIGH IMPEDANCE WAS DUE TO THE BATTERY AND DOES NOT PLAN ON SEEING THE PATIENT UNLESS SHE IS ABLE TO HAVE THE DEVICE REPLACED. THE PATIENT CURRENTLY DOES NOT HAVE A TREATING PHYSICIAN. THERE WAS NO PATIENT MANIPULATION OR TRAUMA THAT OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PATIENT REPORTED THAT SHE WILL WAIT AND SEE IF INSURANCE WILL COVER THE REPLACEMENT IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE SURGEON AGAIN TO DISCUSS HAVING THE VNS EXPLANTED OR REPLACED. HOWEVER, NO SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PROGRAMMING HISTORY DATABASE FOR THE GENERATOR, IT WAS REVEALED THAT THE HIGH IMPEDANCE WAS OBSERVED TWO DAYS EARLIER THAN INITIALLY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL FROM AN MRI FACILITY THAT THE PATIENT'S VNS HAD BEEN PROGRAMMED OFF FOR A WHILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192752 LEAD MODEL 302 LEAD MUZ LIVANOVA USA, INC. 302-20 1471

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female