BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 60/16

    MDR report key: 3211828 · Received July 8, 2013

    Report

    Report Number
    1028232-2013-01882
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 28, 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

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED. ONLY THE DISTAL FRAGMENT WAS RECEIVED. THE MORPHOLOGY OF THE CUTTINGS INDICATES THAT THE FRAGMENTATION OF THE LEAD MOST LIKELY ORIGINATED FROM THE EXPLANT PROCEDURE. THE RETURNED DEVICE WAS VISUALLY AND ELECTRICALLY ANALYZED. VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE SVC SHOCK COIL WHICH OCCURRED MOST LIKELY DURING THE EXPLANT PROCEDURE. IN ADDITION, THE DC RESISTANCES OF THE CONDUCTOR FRAGMENT WERE INVESTIGATED AND PROVED TO BE FLAWLESS. NO PECULIARITIES WERE FOUND. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. IN SUMMARY, NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM WAS NOTED DURING ANALYSIS.

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED AND REPLACED DUE TO SHOCK IMPEDANCES GREATER THAN 150 OHMS. THE PHYSICIAN SUSPECTS THAT THERE WAS A LEAD FRACTURE. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309110 LINOX SMART SD 60/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization