BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIA S 60

    MDR report key: 3050557 · Received April 10, 2013

    Report

    Report Number
    1028232-2013-00947
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 26, 2013
    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

    IN THE ANALYSIS THE CHARACTERISTICS OF THE ELECTRODE WERE EXAMINED . THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS , WHICH MIGHT BE RELATED TO THE CLINICAL COMPLAINT .THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    OUS MDR - AFTER IMPLANTATION, LOSS OF CAPTURE WAS REPORTED. BOTH THE DATE OF THE INCIDENT AND THE EXPLANTATION DATE WERE NOT REPORTED TO US. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148831 SOLIA S 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 377179

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization