BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIO S 60

    MDR report key: 2870130 · Received December 5, 2012

    Report

    Report Number
    1028232-2012-03171
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 22, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE PRODUCTION PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR: MYOCARDIUM PERFORATION WITH SUBSEQUENT PERICARDIAL TAMPONADE WAS REPORTED. THE PERFORATION COULD NOT BE SEEN DIRECTLY, IT WAS ONLY DETECTED LATER DUE TO DROP IN BLOOD PRESSURE. PERICARDIAL PUNCTURE WAS PERFORMED. AFTER THAT, THE STATE OF THE PATIENT WAS DESCRIBED AS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization