BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 1722962 · Received June 15, 2010

    Report

    Report Number
    2649622-2010-06830
    Event Type
    Death
    Date Received
    June 15, 2010
    Date of Event
    March 25, 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
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPEDANCE TREND HAD BEEN UNDER 300 OHMS CONSISTENTLY AND THEN WAS 239 OHMS AND THRESHOLDS WERE 1 V. THE PATIENT WAS PACEMAKER DEPENDENT. A LEAD WARNING WAS NOTED ON THE DEVICE FOR THE VENTRICULAR LEAD. REVIEW OF MANUFACTURER'S DATABASE LATER REVEALED THE PATIENT HAD DIED APPROXIMATELY 6 WEEKS LATER. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. 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. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death