BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 4110008 · Received September 23, 2014

    Report

    Report Number
    1028232-2014-003388
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 14 WEEKS, IT WAS REPORTED THAT THE ICD SHOCKED ADEQUATELY IN (B)(6) 2014 DUE TO VENTRICULAR FIBRILLATION. IT WAS ALSO REPORTED THAT A SCHEDULED FOLLOW-UP WAS PERFORMED ON (B)(6) 2014, DURING WHICH THE ICD COULD NO LONGER BE INTERROGATED. DURING THE EXPLANTATION OF THE ICD ON (B)(6) 2014, SUSPECTED INSULATION DAMAGE WAS OBSERVED ABOUT 2 CM BEHIND THE CONNECTOR. THE LEAD WAS CAPPED AND REMAINS INSIDE THE PATIENT. THE ICD WAS RETURNED TO BIOTRONIK FOR ANALYSIS. NO WORSENING OF THE PATIENT¿S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589634 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization