BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 60

    MDR report key: 3201533 · Received July 2, 2013

    Report

    Report Number
    1028232-2013-01849
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    November 26, 2012
    Report Date
    June 25, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGED THE TYPE OF REPORTABLE EVENT TO MALFUNCTION. 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 SHOWED CUTTINGS IN THE INSULATION WHICH OCCURRED MOST LIKELY DURING SURGERY. IN THE COURSE OF THE FURTHER ANALYSIS, NO 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. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS PATIENT HAD HIGH DFTS POST IMPLANT. THE PHYSICIAN REPLACED THIS LEAD WITH OEM PRODUCTS ON (B)(6) 2012. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303318 LINOX SMART S 60 ICD LEAD NVY BIOTRONIK SE & CO. KG 375012

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization