BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 3021927 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00846
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    December 12, 2012
    Report Date
    March 15, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS OF THE LEAD DEMONSTRATED A RUBBED THROUGH INSULATION AND A FRACTURED CONDUCTOR CABLE TO THE RV SHOCK COIL AT THIS POINT. THIS DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED HIGH SHOCK IMPEDANCE MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. INTERACTION BETWEEN THE LEAD BODY AND THE TRICUSPID VALVE SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - ON (B)(6) 2012, DURING A FOLLOW-UP, THIS LEAD PRESENTED A HIGH SHOCK IMPEDANCE (> 150 OHMS) AND A HIGH PACE/SENSE IMPEDANCE ( > 3000 OHMS). DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT ABOVE THE DISTAL COIL THE INSULATION WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123964 LINOX SMART SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization