BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX T 75

    MDR report key: 3021903 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00743
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 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

    BIOTRONIK'S HOME MONITORING REPORT SHOWED NOISE ON THE RV CHANNEL, WHICH TRIGGERED THE PROPER ALERT THAT LED TO THE DETECTION OF THE LEAD ISSUE. INSPECTION OF THE RETURNED LEAD FRAGMENTS CONFIRMED THAT AN APPROXIMATE 1.7 CM OF THE CONDUCTOR CABLE WAS FOUND TO BE OUTSIDE OF THE LEAD BODY, AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE ROOT CAUSE ANALYSIS IDENTIFIED THAT THE LEAD WAS SUBJECTED TO A SUBSTANTIAL EXTERNAL PULLING FORCE AT SOME POINT AFTER THE LEAD WAS IMPLANTED, RESULTING IN ADDITIONAL INDENTATION MARKS ON THE LEAD BODY 3 MM FROM THE ORIGINAL POSITION OF THE SUTURE SLEEVE. THIS ASSUMPTION IS SUPPORTED BY MARKS ON THE LEAD BODY. AS A RESULT OF THIS EXTERNAL PULLING FORCE, AT LEAST ONE CONDUCTOR WAS DISPLACED AND SUBSEQUENTLY UNDER SEVERE MECHANICAL STRESS WHICH LED TO THE OBSERVED PHENOMENA. FURTHERMORE, THE REST OF FIBROTIC TISSUE ON THE SHOCK COIL INDICATES THAT THE LEAD REMAINED STATIC AT THIS POSITION, WHILE THE PROXIMAL PART OF THE LEAD WAS SHORTENED DUE TO THE EXTERNAL FORCE WHICH CAUSED THE LEAD BODY TO BE PULLED TOWARD THE PROXIMAL END. THIS COMBINATION OF UNIQUE PHENOMENA LED TO A SITUATION WHERE ONE OF THE CABLES WORKED ITSELF THROUGH THE LEAD BODY IN AN INNER CURVE AND IN AN AREA OF STRONG MOVEMENT AND SLACK, LEADING TO THE CLINICAL OBSERVATION. THIS OBSERVATION REPRESENTS AN ABSOLUTELY EXCEPTIONAL CONFIGURATION AND UNEXPECTED CIRCUMSTANCE. THERE WAS NO INDICATION OF A DESIGN DEFICIENCY, AND NO MATERIAL OR MANUFACTURING PROBLEM WAS IDENTIFIED DURING THE ANALYSIS. THE UNEXPLAINED LEAD BODY SHIFT DURING THE SERVICE TIME, MOST LIKELY BEING CAUSED BY A SIGNIFICANT EXTERNAL PULLING FORCE OF UNKNOWN ORIGIN, MUST BE CONSIDERED AS THE MAIN CONTRIBUTING FACTOR TO THIS CASE.

    Description of Event or Problem · 1

    NOISE RECORDED ON THE RV CHANNEL CAUSING AN INAPPROPRIATE SVT DETECTION ON (B)(6) 2013. LEAD REVISION DATE IS YET TO BE SCHEDULED. (B)(6) 2013 - THIS DEVICE WAS RETURNED AND AN EXPLANT DATE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123956 LINOX T 75 ICD LEAD NVY BIOTRONIK SE & CO. KG 351354

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization