BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART S 65

    MDR report key: 3173912 · Received June 17, 2013

    Report

    Report Number
    1028232-2013-01672
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    January 24, 2013
    Report Date
    June 4, 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 CHEST XRAY AFTER PROCEDURE SHOWED THE LEADS WERE IN PLACE. HOWEVER, THE CHEST XRAY ON (B)(6) 2013, IN THE MORNING, SHOW THIS LEAD HAD DISLODGED. THE PATIENT WAS TAKEN BACK TO THE LAB WHERE THE LEAD WAS REPOSITIONED. A CHEST XRAY ON (B)(6) 2013 SHOWED THE LEADS ARE IN GREAT POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273009 LINOX SMART S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization