BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2171938 · Received July 22, 2011

    Report

    Report Number
    2649622-2011-10861
    Event Type
    Death
    Date Received
    July 22, 2011
    Date of Event
    September 9, 2010
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR AND LEAD WERE RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE SYSTEM WAS IMPLANTED LESS THAN ONE YEAR PRIOR TO THE DEATH OF THE PATIENT. FOLLOW UP INFORMATION ABOUT THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE DEATH HAVE BEEN REQUESTED AND NOT YET RECIEVED. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS.

    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 74 YR Death| O