BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 11350866 · Received February 19, 2021

    Report

    Report Number
    1644487-2021-00219
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 25, 2021
    Report Date
    March 22, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENTS, CORRECTED INFORMATION; DUPLICATE MFR REPORT # FOUND AND ALL RELEVANT CONTINUED INFORMATION WILL BE ADDED TO THAT REPORT #.

    Description of Event or Problem · 0

    A CALL WAS RECEIVED 3/3/2021 FROM (B)(4) REQUESTING A QRA FOR EXPLANTED GENERATOR M106 SN: (B)(6). IT WAS INDICATED THE GENERATOR WAS EXPLANTED AND BEING RETURNED DUE TO A HEADER COMPONENT DETACHMENT. QRA# 317136 WAS PROVIDED FOR THE RETURN OF THE GENERATOR. IT WAS FOUND THAT THE EVENTS WERE PREVIOUSLY REPORTED IN MFR REPORT # 1644487-2018-01884. THEREFORE ALL FURTHER UPDATES WILL BE HOUSED IN THAT MFR REPORT #.

    Description of Event or Problem · 1

    DURING REPOSITIONING SURGERY FOR DEVICE MIGRATION (HOUSED IN MFR REPORT # 1644487-2021-00236), THE SILICONE PORTION OF THE SET SCREW HAD COME OUT OF THE GENERATOR AND THEREFORE THE GENERATOR WAS REPLACED. THE SURGEON WAS BACKING THE SCREW AND WHEN HE PULLED THE DRIVER OUT, THE SILICONE HEADER DETACHED. IT WAS UNABLE TO BE ATTACHED OR PUSHED BACK IN. THE HOSPITAL POLICY IS TO KEEP THE DEVICE THEREFORE THE EXPLANTED DEVICE WILL NOT BE RETURNED. THE DEVICE PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248290 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 203471 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR