BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 1933077 · Received December 20, 2010

    Report

    Report Number
    2649622-2010-15346
    Event Type
    Death
    Date Received
    December 20, 2010
    Date of Event
    November 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 SEPARATION AND COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    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 SEPARATION AND COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ASKU

    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. FOLLOW UP REVEALED THE DEATH CERTIFICATE NOTED CAUSE OF DEATH TO BE SEPTIC SHOCK DUE TO PNEUMONIA; OTHER CONTRIBUTING FACTOR WAS CARDIOMYOPATHY. NO AUTOPSY WAS PERFORMED. CLINIC LATER REPORTED PATIENT DEVICE HAD BEEN CHECKED 2 MONTHS PRIOR TO DEATH AND EVERYTHING WAS FUNCTIONING FINE. PATIENT WAS PACEMAKER DEPENDENT. THERE WERE NO PROBLEMS WITH THE DEVICE OR LEAD SYSTEM AS FAR AS THE CLINIC KNOWS.

    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. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP REVEALED THE DEATH CERTIFICATE NOTED CAUSE OF DEATH TO BE SEPTIC SHOCK DUE TO PNEUMONIA; OTHER CONTRIBUTING FACTOR WAS CARDIOMYOPATHY. NO AUTOPSY WAS PERFORMED.

    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 (B)(4) IMPLANTABLE PULSE GENERATOR| 4524 IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 4524 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR