BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 1695399 · Received May 21, 2010

    Report

    Report Number
    2649622-2010-05108
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    July 24, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    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. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. EVALUATION SUMMARY (B) (4) OUTER INSULATION SEPARATION. 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. FOLLOW UP WITH THE CLINIC REVEALED THE PATIENT HAD BEEN IN HOSPICE CARE WITH MULTIPLE HEALTH ISSUES - CARDIOMYOPATHY, HYPOTENSION. THE CAUSE OF DEATH WAS NOT KNOWN TO THE NURSE. THE LAST DEVICE CHECK HAD BEEN IN (B) (6) 2009 WITH NORMAL DEVICE FUNCTION AND STABLE LEADS. THE PATIENT HAD BEEN PACEMAKER DEPENDENT.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER BY A COMPETITOR 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 THE CLINIC REVEALED THE PATIENT HAD BEEN IN HOSPICE CARE WITH MULTIPLE HEALTH ISSUES - CARDIOMYOPATHY, HYPOTENSION. THE CAUSE OF DEATH WAS NOT KNOWN TO THE NURSE. THE LAST DEVICE CHECK HAD BEEN IN (B) (6) 2009 WITH NORMAL DEVICE FUNCTION AND STABLE LEADS. THE PATIENT HAD BEEN PACEMAKER DEPENDENT. ADDITIONAL FOLLOW UP FROM THE PATIENT'S CASE MANAGER REPORTED THE PATIENT WAS IN END STAGE CONGESTIVE HEART FAILURE. THE CASE MANAGER DOES NOT BELIEVE THE DEVICE HAD ANYTHING TO DO WITH THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death