BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1982886 · Received February 9, 2011

    Report

    Report Number
    2649622-2011-00210
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    October 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. ANALYSIS SUMMARY - (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 SUMMARY - (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED AND THAT SAME MONTH, THE DEVICE INDICATED RECOMMENDED REPLACEMENT TIME, BUT THE BATTERY LONGEVITY WAS 5.5 - 8 YEARS. "THIS SUGGEST POR (POWER ON RESET)" WITH A QUESTIONABLE CAUSE. THE CAUSE OF DEATH IS BEING REQUESTED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death