BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 892862 · Received August 9, 2007

    Report

    Report Number
    1028232-2007-00269
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    March 19, 2007
    Report Date
    July 5, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID NOT FIND ANY MATERIAL DEFECT OR MANUFACTURING ERROR. THE LEAD IS WITHIN ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    PRIMARILY COMPLICATION-FREE IMPLANTED PACEMAKER SYSTEM, CONSISTING OF THE PACEMAKER PHILOS DR (S/N 75825418) AND ATRIAL AND VENTRICULAR LEAD (SELOX ST). INTRAOPERATIVELY AND ALSO IN THE POSTOPERATIVE TELEMETRY, THERE WERE GOOD MEASUREMENT RESULTS AND A REGULAR PACEMAKER FUNCTION. HOWEVER, THE ROUTINE LONG-TERM ECG SHOWED A PACING PAUSE OF 5 S. THE TELEMETRY DID NOT SHOW INDICATIONS FOR AN OVERSENSING OF THE VENTRICULAR LEAD. AS A RESULT, THE DECISION WAS MADE TO REVISE THE PACEMAKER DEVICE AND ALSO TO EXCHANGE THE VENTRICULAR LEAD. AFTER THAT, THERE WAS NO MORE INDICATION OF A PACEMAKER MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 60 PACEMAKER DXY BIOTRONIK GMBH AND CO. 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization