BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD

    MDR report key: 4921666 · Received July 17, 2015

    Report

    Report Number
    1028232-2015-02582
    Event Type
    Injury
    Date Received
    July 17, 2015
    Report Date
    July 6, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ANALYSIS IT WAS DETERMINED THAT THIS LEAD IS A LINOX SMART S DX 65/15 AND MODEL NUMBER IS: 365500. THE MANUFACTURE DATE WAS UNABLE TO BE DETERMINED BECAUSE THE SERIAL NUMBER WAS NOT LEGIBLE. UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND CUT AT APPROX. 46 CM PROXIMAL TO THE LEAD TIP. ONLY THE DISTAL LEAD FRAGMENT WAS RECEIVED FOR ANALYSIS. NO SERIAL NUMBER COULD BE IDENTIFIED. THE LEAD FRAGMENT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE ANALYSIS REVEALED MULTIPLE SIGNS OF WEAR ALONG THE LEAD FRAGMENT. IN THE DISTAL AREA OF THE LEAD FRAGMENT A RUBBED THROUGH INSULATION WAS DETECTED. 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. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE. THE DEFORMATION OF THE PROXIMAL SHOCK COIL 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 RETURNED WITHOUT DOCUMENTATION FROM AN UNKNOWN SOURCE. THERE IS NO SERIAL NUMBERS ON THE LEAD. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465187 LEAD NVY BIOTRONIK SE & CO. KG 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization