BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1732844 · Received June 23, 2010

    Report

    Report Number
    2649622-2010-06842
    Event Type
    Death
    Date Received
    June 23, 2010
    Date of Event
    May 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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) OUTER INSULATION BREACHED DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH CLINIC REPORTED PATIENT WAS PACEMAKER DEPENDENT AND LAST DEVICE CHECK ON (B)(6) 2010, SHOWED NORMAL DEVICE FUNCTION. THE PATIENT HAD BEEN IN HOSPICE AND DIED OF CANCER. NO ISSUES WITH DEVICE PERFORMANCE PRIOR TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death LEAD/CCM IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB