BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILDA R 53 US

    MDR report key: 3984484 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002744
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 25, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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

    (B)(6) REPORTED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO NON-CAPTURE AND POSSIBLY DISLODGEMENT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460204 TILDA R 53 US PACER LEAD NVN BIOTRONIK SE & CO. KG 382889

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization