BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 60/16

    MDR report key: 3021764 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00777
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P950037
    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 WAS FOUND DISSECTED INTO TWO FRAGMENTS. THE PROXIMAL FRAGMENT WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS OF THE RETURNED LEAD FRAGMENT DEMONSTRATED A RUBBED THROUGH INSULATION. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE NOISE MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    NOISE WAS PRESENT ON THE RV LEAD CAUSING INAPPROPRIATE DETECTION. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124128 LINOX SD 60/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 363303

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization