BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART S DX 65/17

    MDR report key: 4088603 · Received September 15, 2014

    Report

    Report Number
    1028232-2014-003344
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING ANALYSIS, NO DEVIATIONS WERE NOTED. THE LEAD PROVED TO BE FLAWLESS THROUGHOUT ITS INSPECTION. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE MECHANICAL ANALYSIS WERE WITHIN THE TECHNICAL SPECIFICATIONS. A MEASUREMENT OF THE SURFACE PRESSURE (I.E., THE CONTACT PRESSURE PER UNIT AREA) OF THE LEAD WAS CONDUCTED. FOR THIS PURPOSE A STYLET HAD BEEN INSERTED INTO THE LEAD DURING THE TEST. THE MEASUREMENT DID NOT DEMONSTRATE ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. WITH REGARD TO THE ISSUE MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS OF THE LEAD DID NOT SHOW ANY DEVIATIONS. THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO "PERFORATION OF THE FREE WALL OF THE RV INTO THE PERICARDIUM." LINOX SMART S DX 65/17, SN: (B)(4) WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568733 LINOX SMART S DX 65/17 ICD LEAD NVY BIOTRONIK SE & CO. KG 365501

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization