BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 3242680 · Received July 23, 2013

    Report

    Report Number
    1028232-2013-01993
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 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

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) 2014 - WE WERE INFORMED THIS LEAD WAS EXPLANTED ON (B)(6) 2013 AND REPLACED.

    Description of Event or Problem · 1

    NOISE WAS RECORDED ON THE RV PACE/SENSE CHANNEL CAUSING MULTIPLE INAPPROPRIATE SHOCKS. AT DEVICE INTERROGATION, AN RV P/S IMPEDANCE >3000 WAS RECORDED. NO CAPTURE WAS OBTAINED THROUGH THE LEAD AT MAX OUTPUTS. AN X-RAY DID NOT REVEAL VISUAL INTEGRITY ISSUES. THE PHYSICIAN IS STILL DECIDING BETWEEN IMPLANTING A NEW P/S LEAD OR EXTRACTING THE ENTIRE LEAD. ON (B)(6) 2013 - AS OF TODAY, ALL AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343934 LINOX SMART S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other