BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 12178703 · Received July 15, 2021

    Report

    Report Number
    1644487-2021-00967
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 1, 2021
    Report Date
    November 7, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 ADVERSE EVENT CODES. THE SUPPLEMENTAL MDR 1 INADVERTENTLY OMITTED MEDICAL DEVICE CODE A040101 (FRACTURE) H6. ADVERSE EVENT PROBLEM CODES: THE SUPPLEMENTAL MDR 1 INADVERTENTLY OMITTED MEDICAL DEVICE CODE C070603(FRACTURE PROBLEM).

    Description of Event or Problem · 0

    PER A CLINICAL STUDY SITE, IT WAS REPORTED THAT THE PATIENT HAD SEVERE PAIN AT THE GENERATOR SITE (RATED 9/10 ON PAIN SCALE ) AT THE GENERATOR SITE. AN X-RAY FOUND A DISCONTINUITY CONSISTENT WITH LEAD FRACTURE. THERE WAS NO REPORTED TRAUMA OR MANIPULATION TO THE LEAD AND THE CAUSE OF THE LEAD BREAK IS UNKNOWN. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF LEAD AND GENERATOR DUE TO HIGH IMPEDANCE PRODUCT RETURN IS NOT EXPECTED PER HOSPITAL POLICY. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074607 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 204815 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female