BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILDA R 45 US

    MDR report key: 4110409 · Received September 23, 2014

    Report

    Report Number
    1028232-2014-003380
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ACCORDING TO SORIN CRM USA, INC., THIS LEAD DISLODGED APPROXIMATELY 30 MINUTES AFTER THIS PATIENT LEFT THE OPERATING ROOM. SHE WAS RETURNED TO THE OR IN ORDER TO REPOSITION THE LEAD AND THE STYLET WOULD NOT ADVANCE THROUGH THE LEAD, SO IT WAS EXPLANTED AND REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592331 TILDA R 45 US PACER LEAD NVN BIOTRONIK SE & CO. KG 382884

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization