BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILDA T 60 CE

    MDR report key: 3984413 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002711
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 24, 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

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. DURING THIS ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THIS VENTRICULAR LEAD DISPLAYED IMPEDANCES OF >2000, CAUSING A PACING FAILURE. IT WAS EXPLANTED AND REPLACED. ONLY THE EVENT DATE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461516 TILDA T 60 CE PACER LEAD NVN BIOTRONIK SE & CO. KG 382877

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization