BEUDAMED
    FDA Adverse Event Summary report: N

    LINOX SMART S DX 65/17

    MDR report key: 4822143 · Received June 5, 2015

    Report

    Report Number
    1028232-2015-01913
    Date Received
    June 5, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 26, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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 THE VISUAL INSPECTION A DEFORMATION OF THE FIXATION HELIX WAS FOUND. DAMAGING THE FIXATION HELIX REQUIRES THE PRESENCE OF SEVERAL MECHANICAL STRESS. BASED ON THE DAMAGE SYMPTOMS, IT IS REASONABLE TO ASSUME THAT TENSILE FORCES DURING THE IMPLANTATION PROCEDURE CONTRIBUTED TO THIS OBSERVATION. IN SUMMARY, THE FIXATION HELIX WAS FOUND DEFORMED, WHICH OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE, DISLODGEMENT, AND SENSING ISSUES. 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
    364481 LINOX SMART S DX 65/17 ICD LEAD NVY BIOTRONIK SE & CO. KG 365501

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization