BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIROUET

    MDR report key: 1883721 · Received October 27, 2010

    Report

    Report Number
    2649622-2010-11976
    Event Type
    Death
    Date Received
    October 27, 2010
    Date of Event
    April 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    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 SEPARATION AND COSMETIC ESC 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 ESC AND COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. 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, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. FOLLOW UP REVEALED THE PATIENT WAS LAST SEEN BY THE CLINIC (B)(6) 2010 WITH GOOD PACING, CHARGING, AND SENSING FUNCTIONS OF THE DEVICE AND NO NOTED DEVICE PROBLEMS. IT WAS FURTHER REPORTED THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIROUET ASKU DTB MEDTRONIC PUERTO RICO, INC. IMU49JB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD