BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 3122325 · Received May 21, 2013

    Report

    Report Number
    1028232-2013-01451
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 6, 2013
    Report Date
    May 14, 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.

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING THE MECHANICAL INSPECTION, A STYLET INTENDED TO BE USED WITH THIS LEAD COULD NOT BE PROPERLY INTRODUCED AND ADVANCED WITHIN THE LEAD¿S LUMEN. SUBSEQUENT ANALYSIS REVEALED THE PRESENCE OF COAGULATED BLOOD IN THE LUMEN OF THE LEAD. THESE BLOOD RESIDUALS WERE MOST LIKELY INTRODUCED INTO THE LUMEN OF THE LEAD BY MEANS OF STYLETS USED DURING THE EXPLANTATION PROCEDURE. DUE TO THIS DAMAGE A FUNCTIONAL TEST OF THE LEAD¿S ACTIVE FIXATION MECHANISM WAS NOT PROPERLY FEASIBLE. NO OTHER DEVIATIONS WERE NOTED DURING ANALYSIS THAT MIGHT HAVE LED TO THE CLINICAL OBSERVATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223645 LINOX SMART SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization