BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3913956 · Received July 3, 2014

    Report

    Report Number
    1028232-2014-002371
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    February 4, 2014
    Report Date
    June 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND DISSECTED AT 15.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE EXPLANTATION PROCEDURE. THE RETURNED LEAD FRAGMENT WAS VISUALLY ANALYSED. THE VISUAL INSPECTION REVEALED THAT THE INSULATION WAS, APART FROM THE PRESENT CUTTINGS, FREE OF BREACHES. DUE TO THE DISSECTION, ELECTRICAL ANALYSIS OF THE RETURNED FRAGMENT WAS NOT PROPERLY FEASIBLE. IN SUMMARY, THE LEAD WAS FOUND DISSECTED UPON RECEIPT, WHICH OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENT DID NOT REVEAL ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO NOISE WHICH LED TO INAPPROPRIATE SHOCKS. THIS LEAD WAS RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389797 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization