BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIA S 53

    MDR report key: 8805420 · Received July 18, 2019

    Report

    Report Number
    1028232-2019-03010
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 12, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    UDI-DI
    04035479118266
    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. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS RA LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596862 SOLIA S 53 PACING LEAD NVN BIOTRONIK SE & CO. KG 377177 04035479118266

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization