BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 6234720 · Received January 9, 2017

    Report

    Report Number
    1028232-2017-00015
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 9, 2016
    Report Date
    December 20, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND CUT APPROX. 20 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL PART WAS RETURNED. THE IS-1 CONNECTOR AND BOTH DF-1 CONNECTORS WERE CUT OFF, SO THAT FOUR LEAD FRAGMENTS WERE AVAILABLE FOR ANALYSIS. THE RETURNED LEAD FRAGMENTS WERE VISUALLY AND ELECTRICALLY ANALYZED. THE VISUAL INSPECTION REVEALED THAT THE INSULATION WAS, APART FROM THE PRESENT FRAGMENTATION, FREE OF BREACHES. DURING THE ELECTRICAL ANALYSIS, THE DC RESISTANCES OF THE RECEIVED CONDUCTOR FRAGMENTS WERE MEASURED. NO PECULIARITIES WERE FOUND. FURTHER ANALYSIS OF THE RETURNED LEAD FRAGMENT DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. IN CONCLUSION, THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. BIOTRONIK MONITORS THE POST-MARKET PERFORMANCE OF ITS PRODUCTS CLOSELY IN ORDER TO IDENTIFY ANY TRENDS THAT MAY REVEAL OVER TIME A POTENTIAL MANUFACTURING OR DESIGN ISSUE. THE HISTORIC PERFORMANCE OF THE PRODUCT INVOLVED IN THE CURRENT CASE DOES NOT AT THIS POINT REVEAL ANY SUCH TREND.

    Description of Event or Problem · 1

    THIS LEAD WAS REPLACED DUE TO NOISE. A PORTION OF THIS LEAD REMAINS IN THE BODY CAPPED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16074 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization