BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 3092013 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01240
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 23, 2013
    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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    THE PATIENT WITH THIS LEAD EXPIRED DURING A NORMAL DEVICE CHANGE OUT. WHILE THE PHYSICIAN WAS IMPLANTING THIS LEAD THE PATIENT WENT INTO VT. THE PATIENT WAS EXTERNALLY SHOCKED AND CAME OUT OF IT BUT THEN WENT INTO VT AGAIN AND WAS NOT ABLE TO BE BROUGHT OUT OF IT. THIS LEAD REMAINED IN THE PATIENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193924 LINOX SMART SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death