BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 16811306 · Received April 25, 2023

    Report

    Report Number
    1644487-2023-00515
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    March 30, 2023
    Report Date
    May 22, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE. HEALTH EFFECT - CLINICAL CODE :E2109.

    Description of Event or Problem · 0

    RESPONSE WAS RECEIVED FROM THE PHYSICIAN, THAT THE EXPLANT WAS ONLY DONE FOR PATIENT COMFORT ONLY. AN UPDATE WAS LATER RECEIVED ADDING THAT THE PATIENT CONTINUED TO EXPERIENCE A PAINFUL SHOCKING SENSATION IN THE NECK, THIS TIME WITH THEIR NEWLY REPLACED GENERATOR. AFTER LOWERING THE PATIENT'S PARAMETERS, THE PATIENT STILL FELT DISCOMFORT, AND THE PHYSICIAN DECIDED TO DISABLE THE DEVICE (DIAGNOSTICS WERE OBSERVED OK). THE PATIENT WAS REFERRED FOR A POSSIBLE LEAD REVISION. MFR. REPORT # 1644487-2023-00652 WILL HOUSE ALL FURTHER REPORTS REGARDING THE NEWLY REPORTED PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAINFUL STIMULATION IN THEIR NECK, CHEST, AND JAW; THE STIMULATION WAS ALSO CAUSING THE PATIENT TO EXPERIENCE A SHORTNESS OF BREATH. THE PATIENT USED THEIR MAGNET TO INHIBIT THE STIMULATION, BUT REPORTED STILL FEELING THE PAIN, JUST NOT AS INTENSE. AN UPDATE WAS LATER RECEIVED THAT THE PATIENT HAD THEIR DEVICE DISABLED AFTER THE DISABLEMENT, THE PATIENT NOTED THAT THE PAIN SUBSIDED, DIAGNOSTICS PRIOR TO THE DISABLEMENT WERE NOTED TO BE WITHIN NORMAL LIMITS. THE PHYSICIAN ULTIMATELY REFERRED THE PATIENT FOR AN EXPLANT IN ORDER TO BETTER ASSES THE EVENTS. THE PHYSICIAN SUSPECTED THAT ALTHOUGH DIAGNOSTICS WERE OK, THE LEAD APPEARS TO HAVE ERODED THE PATIENT'S VAGUS NERVE SHEATH AND HAS COME IN DIRECT CONTACT WITH THE NERVE. DETERMINATION ON THE REPORT OF THE VAGUS NERVE ERODING IS NOT POSSIBLE; HOWEVER, THIS WOULD ALSO LIKELY RESULT IN A LEAD IMPEDANCE ISSUE. DIAGNOSTICS WERE OBSERVED AS OK AND THEREFORE NOT INDICATIVE OF A MALFUNCTION. AN IMPLANT CARD WAS RECEIVED REPORTING THE GENERATOR REPLACEMENT. THE REASON FOR REPLACEMENT WAS MARKED AS 'OTHER.' THE PATIENT FOLLOWED UP TO HAVE THEIR REPLACEMENT DEVICE TURNED ON AND DENIED ANY COMPLAINTS. PRODUCT RETURN ATTEMPTS WILL NOT BE MADE AS THE FACILITY IS LISTED AS A NO-RETURN SITE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091780 PULSE GEN MODEL 106 GENERATOR MUZ LIVANOVA USA, INC. 106 205363 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other| R