BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2111153 · Received June 2, 2011

    Report

    Report Number
    2649622-2011-07702
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    April 30, 2008
    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
    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 PRIMARY ANALYSIS FINDINGS 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 WITH NO INFORMATION. A DATABASE SEARCH REVEALED THAT THE PATIENT EXPIRED LESS THAN ON YEAR AFTER IMPLANT AND THE DEATH OCCURRED 3 YEARS AGO. NO REASONABLE CONTACT INFORMATION EXISTS. NO PRIOR CONTACTS, COMPLAINTS, OR ALLEGATIONS HAVE BEEN RECIEVED REGARDING 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| O