BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2243647 · Received September 12, 2011

    Report

    Report Number
    2649622-2011-13816
    Event Type
    Death
    Date Received
    September 12, 2011
    Date of Event
    February 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL LEAD SEGMENT WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THERE WAS OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS ONLY WAS PERFORMED. (B)(4) THE PROXIMAL LEAD SEGMENT WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THERE WAS OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS ONLY WAS PERFORMED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) THE PROXIMAL LEAD SEGMENT WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THERE WAS OUTER INSULATION COSMETIC DEPRESSION. (B)(4) THE PROXIMAL LEAD SEGMENT WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THERE WAS OUTER INSULATION COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    ASKU.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. THE PATIENT DIED APPROXIMATELY THREE MONTHS POST THE IMPLANT OF THE IPG SYSTEM. A CAUSE OF DEATH WAS REQUESTED, AND NONE WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death