BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1674998 · Received May 5, 2010

    Report

    Report Number
    2649622-2010-01916
    Event Type
    Death
    Date Received
    May 5, 2010
    Date of Event
    April 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND DECEASED AT HOME. THE PATIENT'S DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. AT THIS TIME, THE CAUSE OF DEATH IS CARDIAC-RELATED AND IS SUSPECTED TO BE SUDDEN CARDIAC DEATH OR AN ARRHYTHMIA. THE CORONER IS AWAITING THE DEVICE ANALYSIS PRIOR TO ISSUING A FORMAL CAUSE OF DEATH. THERE HAS BEEN NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL INDICATING THE PATIENT'S DEATH WAS DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death 5076 IMPLANTABLE PACING LEAD