BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2471453 · Received February 28, 2012

    Report

    Report Number
    1644487-2012-00537
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 6, 2012
    Report Date
    October 28, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME; MODEL #, LOT #, SERIAL #, EXPIRATION DATE; MANUFACTURE DATE; CORRECTED DATA: PRODUCT INFORMATION RECEIVED, THEREFORE AN UPDATE FROM THE INFORMATION PROVIDED ON THE INITIAL REPORT. MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012, WHEN THE PATIENT'S PRODUCT INFORMATION WAS PROVIDED BY THE IMPLANTING HOSPITAL. X-RAYS WERE RECEIVED FROM THE PSYCHIATRIST ON (B)(6) 2012. AP AND LATERAL VIEWS OF THE CHEST AND NECK DATED (B)(6) 2012, WERE RECEIVED. BASED ON THE X-RAY IMAGES PROVIDED, THE CAUSE OF THE HIGH IMPEDANCE WAS NOT DETERMINED. THERE WERE NO LEAD DISCONTINUITIES OR SHARP BENDS SEEN IN THE VISIBLE PORTIONS OF THE LEAD BODY. HOWEVER, THE PRESENCE OF A MICRO-FRACTURE COULD NOT BE RULED OUT. ALSO, SINCE A PORTION OF THE LEAD WAS LOCATED BEHIND THE GENERATOR, THE ENTIRE LEAD COULD NOT BE ASSESSED. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A VNS TREATING PSYCHIATRIST REPORTED THAT THE VNS DEPRESSION PATIENT PRESENTED WITH HIGH LEAD IMPEDANCE THAT DAY DURING A CLINICAL VISIT. THE PATIENT HAD PREVIOUSLY BEEN SEEN BY A DIFFERENT PSYCHIATRIST BUT THE DEVICE HAD NOT BEEN CHECKED IN OVER TWO YEARS. THE PATIENT'S DEVICE IS CURRENTLY PROGRAMMED TO OUTPUT=1.25MA/FREQUENCY=30HZ/PULSE WIDTH=750USEC/ON TIME=30SEC/OFF TIME=5MIN. BOTH SYSTEM AND NORMAL MODE DIAGNOSTICS SHOWED OUTPUT=LIMIT/DCDC=7/LEAD IMPEDANCE=HIGH/EOS=NO. THE PATIENT DID NOT REPORT ANY ADVERSE EVENTS AND ACTUALLY STATED THAT HER DEPRESSION HAS GREATLY IMPROVED. THE PATIENT STATED THAT THERE HAS BEEN NO TRAUMA TO THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PSYCHIATRIST'S NURSE REPORTED THAT X-RAYS WERE TAKEN OF THE PATIENT AND THAT THE X-RAY REPORT DID NOT SAY MUCH. SHE STATED THAT THE X-RAYS WOULD BE SENT TO THE MANUFACTURER FOR REVIEW BUT THEY HAVE NOT YET BEEN RECEIVED BY THE MANUFACTURER TO DATE. ATTEMPTS WERE MADE TO THE HOSPITAL THE PATIENT WAS IMPLANTED AT TO OBTAIN THE PATIENT'S IMPLANTED PRODUCT INFORMATION BUT THIS INFORMATION HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED.

    Description of Event or Problem · 1

    A BATTERY LIFE CALCULATION WAS PERFORMED ON (B)(6) 2012, WITH THE PROGRAMMING HISTORY AVAILABLE WHICH SHOWED 1.21 YEARS UNTIL THE ELECTIVE REPLACEMENT INDICATOR SHOWS AS YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MUZ LIVANOVA USA, INC. 302-20 200104

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR