BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3153363 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05967
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 17, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY CUT BUT NOT BREACHED, AND VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT HELIX TEST RESULTS WERE WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD PERFORATED THE PATIENT'S MYOCARDIUM DURING THE IMPLANT ATTEMPT. THE PATIENT EXPERIENCED PERICARDIAL TAMPONADE. THE LEAD WAS NOT IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255337 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Life Threatening