BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 9922524 · Received April 3, 2020

    Report

    Report Number
    1644487-2020-00557
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    February 19, 2020
    Report Date
    April 3, 2020
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO GENERATOR REPLACEMENT DUE TO BATTERY DEPLETION. AFTER THE GENERATOR WAS REPLACED, HLI WAS SEEN INTRA-OPERATIVELY. THE PATIENT THEN HAD THEIR LEAD REPLACED. THE HLI WAS RESOLVED AFTER THE FULL REPLACEMENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384194 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS - HOUSTON 300-20 3027

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR