BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/18

    MDR report key: 3122301 · Received May 21, 2013

    Report

    Report Number
    1028232-2013-01404
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 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

    NOISE IS BEING SEEN ON RV LEAD ONLY FROM A STORED IEGM. ALL DIAGNOSTIC VALUES ARE STABLE, UNCHANGED AND WITHIN NORMAL LIMITS. CLINICAL EVALUATION WAS UNABLE TO REPRODUCE NOISE. WE ADVISED THEM TO CONTINUE TO MONITOR CLOSELY AT THIS TIME. (B)(6) 2013 - WE WERE NOTIFIED THAT THIS LEAD WAS CAPPED ON (B)(6) 2013.

    Description of Event or Problem · 1

    NOISE IS BEING SEEN ON RV LEAD ONLY FROM A STORED IEGM. ALL DIAGNOSTIC VALUES ARE STABLE, UNCHANGED AND WITHIN NORMAL LIMITS. CLINICAL EVALUATION WAS UNABLE TO REPRODUCE NOISE. WE ADVISED THEM TO CONTINUE TO MONITOR CLOSELY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224830 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other