BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELOX JT 45

    MDR report key: 5576312 · Received April 14, 2016

    Report

    Report Number
    1028232-2016-01527
    Event Type
    Death
    Date Received
    April 14, 2016
    Date of Event
    August 10, 2011
    Report Date
    December 12, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    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

    ON 4/12/2016 - BASED ON THE ANALYSIS, IT WAS DETERMINED THAT THIS EVENT BE REPORTED TO THE FDA. THE PERFORMANCE OF THE LEADS UNDER COMPLAINT WERE SCRUTINIZED. THE ANALYSIS OF THE VENTRICULAR LEAD DEMONSTRATED A RUBBED THROUGH INSULATION. BASED ON THE CHARACTERISTICS, THE GEOMETRY AND THE LOCATION OF THESE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE AND CONTINUOUS MECHANICAL STRESS. THE INTERACTION WITH THE ATRIAL LEAD SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE DAMAGED LEAD TIPS AND THE DEFORMATION OF THE INNER COIL HAPPENED MOST LIKELY DURING THE EXTRACTION OF THE LEADS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION FROM MEDTRONIC, INC. PER THE (B)(6), THIS PATIENT EXPIRED ON (B)(6) 2011. THE FOLLOWING PHYSICIAN'S OFFICE HAS NO INFORMATION REGARDING THIS PATIENT'S DEATH. 4/12/2016 - BASED ON THE ANALYSIS, IT WAS DETERMINED THAT THIS EVENT BE REPORTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234010 SELOX JT 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 346369

    Patients

    Seq Age Sex Outcome Treatment
    1 Death