BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 65/16 STEROID

    MDR report key: 3232143 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01925
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 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

    INAPPROPRIATE THERAPY DUE TO NOISE SEEN ON THE RV AND FF IEGMS. ALL SENSING, THRESHOLDS AND IMPEDANCES ARE STABLE AND UNCHANGED AT THIS TIME. UNABLE TO REPRODUCE NOISE WITH PROVOCATIVE TESTING. WILL CONTINUE TO MONITOR LEAD AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332242 KENTROX SL 65/16 STEROID ICD LEAD NVY BIOTRONIK SE & CO. KG 347351

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization