BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3021757 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00806
    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
    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 WAS FOUND DISSECTED AT APPROX. 25.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. THE DISTAL PART OF THE LEAD WAS NOT RETURNED FOR ANALYSIS. THE PROXIMAL LEAD FRAGMENT WAS INSPECTED. THE ANALYSIS REVEALED A BEND OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. BLOOD PENETRATED THE LEAD. IT IS REASONABLE TO ASSUME THAT THE DAMAGES OCCURRED DURING THE EXPLANT PROCEDURE. DURING THIS ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE ANALYSIS OF THE RETURNED LEAD FRAGMENT DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    NOISE ON RV LEAD WAS SEEN. INAPPROPRIATE SHOCKS WERE DELIVERED DUE TO THE NOISE. THE RV LEAD WAS CAPPED AND REPLACED. A PORTION OF THE LEAD WAS RETURNED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124716 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization