BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2230065 · Received August 31, 2011

    Report

    Report Number
    2649622-2011-13756
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    May 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
    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, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. LEAD ANALYSIS IS IN PROGRESS AND WILL BE FORWARDED ONCE COMPLETE.

    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 SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED. THE DEATH OCCURRED LESS THAN ONE YEAR AFTER IMPLANT. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN RECEIVED IN REGARDS TO THE DEVICE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS. FOLLOW UP HAS BEEN INCONCLUSIVE AND ALL LEADS HAVE BEEN EXHAUSTED.

    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 86 YR Death| O