BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SENSE

    MDR report key: 1905445 · Received November 23, 2010

    Report

    Report Number
    2649622-2010-12124
    Event Type
    Death
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ASKU

    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 ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT 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 MANUFACTURER FOLLOWING THE PATIENT DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP WITH CLINIC REPORTED THE CAUSE OF DEATH IS UNKNOWN TO THEM. THERE IS NO ALLEGATION THAT THERE WERE ANY DEVICE OR LEAD PERFORMANCE ISSUES PRIOR TO DEATH. LAST CARELINK HAD BEEN ONE MONTH PRIOR TO DEATH AND NOTED 26 BRIEF VENTRICULAR HIGH RATES WITH NO DELIVERED THERAPY. DEATH CERTIFICATE REVEALED THE CAUSE OF DEATH WAS CARDIAC TAMPONADE, PERICARDIAL EFFUSION (LIKELY MALIGNANT), AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP WITH CLINIC REPORTED THE CAUSE OF DEATH IS UNKNOWN TO THEM. THERE IS NO ALLEGATION THAT THERE WERE ANY DEVICE OR LEAD PERFORMANCE ISSUES PRIOR TO DEATH. LAST CARELINK HAD BEEN ONE MONTH PRIOR TO DEATH AND NOTED 26 BRIEF VENTRICULAR HIGH RATES WITH NO DELIVERED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR