BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SENSE

    MDR report key: 1894588 · Received November 10, 2010

    Report

    Report Number
    2649622-2010-12057
    Event Type
    Death
    Date Received
    November 10, 2010
    Date of Event
    April 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    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) DEVICE RETURNED AND ANALYZED. NO ANOMALIES FOUND. (B)(4): PROXIMAL SEGMENT OF THE LEAD RETURNED, NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC. (B)(4): PROXIMAL SEGMENT OF THE LEAD RETURNED. NO ANOMALIES FOUND, OUTER INSULATION COSMETIC ESC.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED (B)(6) 2010. CAUSE OF DEATH UNKNOWN AND ANALYSIS OF THE DEVICE WAS REQUESTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L