BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 2961483 · Received February 14, 2013

    Report

    Report Number
    2649622-2013-02428
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    January 11, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOLLOW-UP IS IN PROGRESS. THE DECISION TO REPORT WAS DETERMINED BASED ON INFORMATION THAT WAS AVAILABLE AT THE TIME OF DECISION. SHOULD ADDITIONAL INFORMATION BECOME KNOWN THROUGH FOLLOW-UP, IT WILL BE ADDED TO THE EVENT AND PROCESSED ACCORDINGLY. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED. CONCOMITANT PRODUCTS: 4024-52 IMPLANTABLE PACING LEAD 2000 (B)(6); 419388 IMPLANTABLE PACING LEAD 2005 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED FROM CENTRAL TEXAS PALLIATIVE CARE ASSOCIATES INDICATING PER THE DEATH SUMMARY, THE PATIENT'S CAUSE OF DEATH WAS LEFT VENTRICULAR DYSFUNCTION DUE TO COMPLETE HEART BLOCK, CARDIOMYOPATHY, HYPERTENSION AND RHEUMATIC HEART DISEASE. THE PATIENT HAD A HISTORY SIGNIFICANT FOR ATRIAL FIBRILLATION AND ATRIAL FLUTTER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN PERSON WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST THE DEVICE SYSTEM IMPLANT.

    Description of Event or Problem · 1

    A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN PERSON WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST THE DEVICE SYSTEM IMPLANT. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65167 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death C2TR01 IMPLANTABLE CARDIAC RESYNCH. THERAPY PACEMA