BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIA S 45

    MDR report key: 10537871 · Received September 15, 2020

    Report

    Report Number
    1028232-2020-03933
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 15, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    UDI-DI
    04035479118259
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    LEAD WAS EXPLANTED AND REPLACED ON 9/15/2020 DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001264 SOLIA S 45 PACING LEAD NVN BIOTRONIK SE & CO. KG 377176 04035479118259

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization