BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2112638 · Received June 3, 2011

    Report

    Report Number
    2649622-2011-07723
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    November 4, 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
    CO, US
    Reporter Occupation
    RISK MANAGER

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

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS RETURNED AFTER BEING REMOVED PRIOR TO CREMATION OF A DECEASED PATIENT. A DATABASE SEARCH REVEALED THAT THE PATIENT HAD EXPIRED LESS THAN (B)(6) AFTER IMPLANT OF THE DEVICE. FOLLOW UP HAS BEEN INCONCLUSIVE SO FAR, ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE 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 81 YR Death| O