BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 3002186 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00710
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    March 7, 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.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO NOISE. AT THAT TIME, THE PHYSICIAN CHOSE TO ALSO EXPLANT THE ASSOCIATED ICD "TO PREVENT INFECTION AND ADDITIONAL SURGERY". THIS SYSTEM WAS SENT TO PATHOLOGY AND IS NOT EXPECT TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106070 LINOX SMART SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization