BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 2882169 · Received November 13, 2012

    Report

    Report Number
    1028232-2012-02820
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION OF THE LEAD SHOWED DEFORMATIONS OF THE RV SHOCK COIL WHICH OCCURRED MOST LIKELY DURING SURGERY. NO FURTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. THERE WAS NEITHER FOR THE LEAD NOR FOR THE ICD ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED AND REPLACED BECAUSE THERE WAS NOISE ON THE SENSING CHANNEL AND THE FAR FIELD CHANNEL. AFTER TROUBLESHOOTING, THE PHYSICIAN WAS UNABLE TO DIAGNOSE THE ISSUE SO THE DEVICE AND RV LEAD WERE BOTH REMOVED. SHOULD ADD¿L INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization