BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART TD 65/16

    MDR report key: 3952847 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002480
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 14, 2014
    Report Date
    July 10, 2014
    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

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. ITS PERFORMANCE WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE ANALYSIS REVEALED SIGNS OF WEAR AT THE DISTAL PART OF THE LEAD WITH A DAMAGED INSULATION IN THIS AREA. THIS INSULATION DAMAGE CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE NOISE MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AND LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO A SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 19 MONTHS, OVERSENSING WITH INAPPROPRIATE SHOCKS WAS REPORTED. THE LEAD WAS EXPLANTED AND NOT RETURNED TO BIOTRONIK. APART FROM THE SHOCKS, NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430693 LINOX SMART TD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359073

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization