BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 18933486 · Received March 19, 2024

    Report

    Report Number
    1644487-2024-00318
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 23, 2024
    Report Date
    April 18, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿MIGRATION¿ IS NOT AVAILABLE. (NOTE THAT ALTHOUGH MIGRATION IS AN AVAILABLE MEDICAL DEVICE PROBLEM CODE, IN THIS REPORT¿S CONTEXT, THE MIGRATION DOES NOT REFLECT A PROBLEM WITH THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE. THEREFORE, A DEVICE PROBLEM CODE DOES NOT ADEQUATELY CAPTURE THE PATIENT¿S ADVERSE EVENT .) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR A SURGERY CONSULT DUE TO MIGRATION OF BOTH THEIR GENERATOR AND LEAD AND PAIN CAUSED BY THE GENERATOR. THE PATIENT STATED THAT THEY LOST WEIGHT, CAUSING THE IPG TO BE TOO LARGE IN THEIR GENERATOR POCKET AND THUS CAUSING PAIN. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM THE PATIENT'S PHYSICIAN REGARDING THE REPORTED DEVICE MIGRATION AND SURGERY CONSULT. THE PHYSICIAN STATED THAT THEY ARE NOT AWARE OF THE CURRENT LEAD POSITION AND HAVE NOT RECEIVED ANY REPORTS REGARDING THE LEAD POSITION. IN REGARD TO THE GENERATOR MIGRATION, THE PHYSICIAN STATED THAT THIS WAS CONJECTURE WHICH HAS NO BASIS, AS THE MOST RECENT X-RAY IMAGE, TAKEN BEFORE THE REPORTED PAIN AND MIGRATION, SHOWED THE GENERATOR OVER THE ANTERIOR CHEST WALL. THE PHYSICIAN DID STATE THAT THEY HAVE OBSERVED THE PATIENT MANIPULATING THE GENERATOR TO SHIFT ITS POSITION DUE TO DISCOMFORT. IT WAS ALSO REPORTED BY THE PHYSICIAN THAT THE PENDING SURGERY WAS TO ADDRESS THE PATIENT'S REPORTED PAIN AND MIGRATION. THE SURGERY WAS NOTED TO BE FOR PATIENT COMFORT ONLY. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361386 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205073 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other