BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 11935849 · Received June 3, 2021

    Report

    Report Number
    1644487-2021-00760
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 12, 2021
    Report Date
    November 7, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 MEDICAL DEVICE CODE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY OMITTED CODE A072102. F10 HEALTH EFFECT CLINICAL CODE, CORRECTED DATA: SUPPLEMENTAL REPORT #1 INADVERTENTLY REPORTED CODE E233001 AND SHOULD NOT HAVE AS THAT EVENT IS NOT REPORTABLE. H4 MANUFACTURE DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY OMITTED SUSPECT DEVICE MANUFACTURING DATE. H6 TYPE OF INVESTIGATION, CORRECTED DATA: INITIAL REPORT INADVERTENTLY OMITTED CODE B01 AND B20, HOWEVER THE SUSPECT DEVICE HAS SINCE BEEN EXPLANTED AND IS THEREFORE REPORTED AS B17 IN THIS REPORT. H6 INVESTIGATION FINDINGS, CORRECTED DATA: INITIAL REPORT INADVERTENTLY USED CODE C02023 INSTEAD OF C0208.

    Description of Event or Problem · 0

    PATIENT REPORTED SOME MILD PAIN UNDER HER LEFT BREAST.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A FULL REPLACEMENT. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN AND HAD LOW LEAD IMPEDANCE. PATIENT STATED SHE HAD NO SIDE EFFECTS OR CHANGES RECENTLY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826685 BIPOL LEAD MODEL 300 LEAD LYJ LIVANOVA USA, INC. 300-20

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female