BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1852959 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09087
    Event Type
    Death
    Date Received
    October 5, 2010
    Date of Event
    August 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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) CONNECTOR OTHER, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER INSULATION TORN. 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) CONNECTOR OTHER, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), INNER INSULATION TORN. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOLLOWING THE PATIENT 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. FOLLOW UP LATER REVEALED THE DEATH CERTIFICATE NOTED CAUSE OF DEATH TO BE CARDIAC ARRHYTHMIA.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOLLOWING THE PATIENT DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP REVEALED THE DEATH CERTIFICATE NOTED CAUSE OF DEATH TO BE CARDIAC ARRHYTHMIA. NO AUTOPSY WAS PERFORMED. THE PHYSICIAN REPORTED THAT PER THE PATIENTS EKG, "THE DEVICE WAS PACING FOR HIM." THE LAST TIME THE PATIENT WAS SEEN AT THE CLINIC WAS (B)(6) 2010 FOR SPINAL STENOSIS. THE PATIENTS HEALTH HAD BEEN FAILING OVER THE PREVIOUS 2 -3 MONTHS AND THE PATIENT HAD NOT BEEN EATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death VEDR01 IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| VEDR01 IMPLANTABLE PULSE GENERATOR