BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 3082856 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01116
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    August 8, 2011
    Report Date
    April 15, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P950037
    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

    DURING AN UNSCHEDULED VISIT ON (B)(6) 2011, ORIGINALLY FOR A FOLLOW UP WOUND CHECK, THE PATIENT WAS NOTED TO HAVE AN ELEVATED SHOCK IMPEDANCE OF GREATER THAN 150 OHMS. SIX MANUAL SHOCK IMPEDANCE MEASUREMENTS PERFORMED ALL AT 119 OHMS. SHOCK IMPEDANCE WAS CORRECTED DURING AN LV LEAD REVISION ON (B)(6) 2011. OP REPORT INDICATES THAT RV LEAD SLACK WAS INTRODUCED. ELEVATED SHOCK WAS THOUGHT TO BE RELATED TO A SET SCREW. ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS ACTIVELY IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185677 LINOX SMART SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization