BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 2162729 · Received July 14, 2011

    Report

    Report Number
    2649622-2011-10843
    Event Type
    Death
    Date Received
    July 14, 2011
    Date of Event
    May 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S10
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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): THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED 7 DAYS AFTER IMPLANT. THE PHYSICIAN HAD NO OFFICIAL CAUSE OF DEATH AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO SPECIFIC COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4523 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| O