BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3932230 · Received July 14, 2014

    Report

    Report Number
    1028232-2014-002400
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. THE VISUAL INSPECTION REVEALED SIGNS OF ABRASION ALONG THE LEAD BODY. IN THE AREA OF THE TRICUSPID VALVE THE INSULATION WAS FOUND DAMAGED AND THE CONDUCTOR CABLE TO THE RV SHOCK COIL WAS FOUND OUTSIDE THE LEAD BODY. FURTHERMORE, THE LEAD BODY SHOWED STRONG SIGNS OF ABRASION IN THIS AREA. THESE DAMAGES CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THIS DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE IN THE AREA OF THE TRICUSPID VALVE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES SUCH AS THE DEFORMATIONS OF THE SHOCK COILS AND CUTTINGS INTO THE LEAD BODY MOST LIKELY OCCURRED DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO NOISE. UPON EXPLANT, IT APPEARED THAT THERE WAS AN EXPOSED WIRE. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411085 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization