BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SD01 65/18

    MDR report key: 3777554 · Received April 29, 2014

    Report

    Report Number
    1028232-2014-01361
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODE RETURNED WAS EXTENSIVELY ANALYZED. DURING THE INVESTIGATION, THE ELECTRODE WAS VISUALLY , ELECTRICALLY AND MECHANICALLY CHECKED. DURING THIS INSPECTION SHOWED NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS, WHICH MIGHT BE RELATED TO THE CLINICAL COMPLAINT. THE ELECTRODE PROVED TO BE CONFORM TO SPECIFICATION AND PROPERLY. IN SUMMARY, THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 8 WEEKS, A THRESHOLD INCREASE OF > 3.0V @ 1.5MS WAS REPORTED. IMPEDANCE AND SENSING WERE NORMAL. THE LEAD WAS THEN EXPLANTED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257348 SD01 65/18 PACER LEAD NVN BIOTRONIK SE & CO. KG 365488

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization