BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 1673433 · Received May 5, 2010

    Report

    Report Number
    2649622-2010-01913
    Event Type
    Death
    Date Received
    May 5, 2010
    Date of Event
    March 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) INNER INSULATION SEPARATION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE ATRIAL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. IT HAD BEEN REPORTED THE PATIENT HAD GONE TO THE EMERGENCY ROOM DUE TO A FALL WITH MULTIPLE CONTUSIONS AS HAD BEEN TAKING ANTICOAGULANTS. IT WAS REPORTED NO HEAD OR CAT SCAN WAS DONE AND THE PATIENT DIED UNEXPECTEDLY. A CRANIAL BLEED WAS SUSPECTED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other (B) (4) IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD