BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S DX 65/15

    MDR report key: 4296746 · Received December 4, 2014

    Report

    Report Number
    1028232-2014-005953
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    October 3, 2014
    Report Date
    November 19, 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

    PLEASE NOTE THAT THE LEAD HAD NOT BEEN RETURNED TO US WHEN THE INITIAL REPORT WAS SENT TO YOU. WHEN THE LEAD WAS RETURNED TO US, IT WAS OBSERVED THAT THE SERIAL NUMBER INDICATED IN OUR INITIAL REPORT WAS INCORRECT ((B)(4)). THE LINOX SMART S DX LEAD AND THE ICD WERE ANALYSED. THE ANALYSIS OF THE LINOX SMART SDX LEAD DEMONSTRATED A DAMAGED INSULATION AT APPROX. 34 CM DISTAL TO THE IS-1CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. THESE FINDINGS CAN BE CONSIDERED TO BE THE ROOT CAUSE FOR THE CLINICAL OBSERVATION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR FIRST RIB ENTRAPMENT. 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 3 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPY WAS REPORTED. A POSSIBLE LEAD FRACTURE WAS SUSPECTED. LEAD AND ICD WERE REPLACED. THE LEAD WAS 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
    784424 LINOX SMART S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization