BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2243605 · Received September 12, 2011

    Report

    Report Number
    2649622-2011-13814
    Event Type
    Death
    Date Received
    September 12, 2011
    Date of Event
    May 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE PATIENT'S CARDIOLOGIST. THE CAUSE OF DEATH HAS BEEN REPORTED AS OVARIAN CANCER. CIRCUMSTANCES SURROUNDING THE DEATH INCLUDED SEPTIC SHOCK. THE PATIENT WAS NOT PACEMAKER DEPENDANT, NO AUTOPSY WAS PERFORMED AND THE PHYSICIAN INDICATED THE DEATH AND DEVICE SYSTEM WERE NOT RELATED. CORRECTION FOR THE DEVICE (B)(4). (B)(4). EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4):THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION FOR THE DEVICE (B)(4). THE (B)(4) WAS INADVERTENTLY ENTERED RATHER THAN 2993. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY TEN MONTHS POST OF THE SYSTEM. A CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death