BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2072250 · Received April 28, 2011

    Report

    Report Number
    2649622-2011-07358
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    December 4, 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 U.S. 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) ANALYSIS UNKNOWN/NOT ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED SIX SUCCESSFUL SHOCKS FOR VENTRICULAR FIBRILLATION (VF) WITH RHYTHM RETURNING TO SINUS AFTER EACH SHOCK. RHYTHM REVERTED BACK TO VF WITHIN 4 - 5 BEATS OF THESE SHOCKS. THE EPISODE DID NOT MEET THE CURRENT TERMINATION CRITERIA THEREBY RENDERING THE DEVICE UNAVAILABLE FOR ADDITIONAL SHOCKS. FURTHER REPORTED "DEVICE HAS FUNCTIONED WITHIN SPECIFICATIONS." THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 Death