BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIO S 60

    MDR report key: 2844865 · Received November 2, 2012

    Report

    Report Number
    1028232-2012-02696
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF (B)(6), IT WAS REPORTED THAT THE PACING IMPEDANCE INCREASED (>2500 OHM). NO WORSENING OF SENSING AND THRESHOLD WAS NOTED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIO S 60 PACER LEAD NVZ BIOTRONIK SE & CO. KG 370946

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization