BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z

    MDR report key: 1890308 · Received November 3, 2010

    Report

    Report Number
    2649622-2010-12025
    Event Type
    Death
    Date Received
    November 3, 2010
    Date of Event
    July 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS IN A DECLINING STATUS AND MADE A DO NOT RESUSCITATE WITH COMFORT MEASURES. THE PATIENT DIED LATER THAT EVENING WITH NO INDICATION OF ANY DEVICE OR LEAD PERFORMANCE ISSUES OR CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY TWO MONTHS FOR A LEFT ABOVE KNEE AMPUTATION, RENAL AND RESPIRATORY FAILURE, AND AN INFECTION. PATIENT WAS DISCHARGED TO A LONG TERM CARE FACILITY AND DIED ON (B)(6) 2010, APPROXIMATELY TWO MONTHS AFTER DISCHARGE FROM THE HOSPITAL. THE RELATEDNESS OF THE SUBJECT DEATH TO THE LEAD IS REPORTED AS "UNKNOWN". THE PRIMARY CAUSE OF DEATH IS REPORTED AS "UNKNOWN". THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY TWO MONTHS FOR A LEFT ABOVE KNEE AMPUTATION, RENAL AND RESPIRATORY FAILURE, AND AN INFECTION. PATIENT WAS DISCHARGED TO A LONG TERM CARE FACILITY AND DIED ON (B)(6) 2010, APPROXIMATELY TWO MONTHS AFTER DISCHARGE FROM THE HOSPITAL. THE RELATEDNESS OF THE SUBJECT DEATH TO THE LEAD IS REPORTED AS "UNKNOWN". THE PRIMARY CAUSE OF DEATH IS REPORTED AS "UNKNOWN". THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED AT (B)(6) AND LATER DIED AT LONG TERM CARE FACILITY. THE CAUSE OF DEATH, AUTOPSY STATUS, AND RETURN STATUS OF THE DEATH REMAINS UNKNOWN. THERE IS NO ALLEGATION OF DEVICE RELATEDNESS BY A HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY TWO MONTHS FOR A LEFT ABOVE KNEE AMPUTATION, RENAL AND RESPIRATORY FAILURE, AND AN INFECTION. PATIENT WAS DISCHARGED TO A LONG TERM CARE FACILITY AND DIED ON (B)(6) 2010, APPROXIMATELY TWO MONTHS AFTER DISCHARGE FROM THE HOSPITAL. THE RELATEDNESS OF THE SUBJECT DEATH TO THE LEAD IS REPORTED AS "UNKNOWN". THE PRIMARY CAUSE OF DEATH IS REPORTED AS "UNKNOWN". THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED AT (B)(6) AND LATER DIED AT LONG TERM CARE FACILITY. THE CAUSE OF DEATH, AUTOPSY STATUS, AND RETURN STATUS OF THE DEATH REMAINS UNKNOWN. THERE IS NO ALLEGATION OF DEVICE RELATEDNESS BY A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5033 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| L| R COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB