BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 3193482 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01803
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    October 1, 2012
    Report Date
    June 11, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. THE VISUAL INSPECTION SHOWED DEFORMATIONS OF THE DISTAL AND PROXIMAL SHOCK COIL WHICH OCCURRED MOST LIKELY DURING SURGERY. DURING FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. THE PATIENT LIKELY HAS TWIDDLER'S SYNDROME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294825 LINOX SMART SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization