BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3093617 · Received May 6, 2013

    Report

    Report Number
    2649622-2013-05376
    Event Type
    Death
    Date Received
    May 6, 2013
    Date of Event
    July 12, 2012
    Report Date
    May 30, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT ID: SEDR01, IMPLANTED: (B)(6) 2007; PRODUCT ID: 5076-45, IMPLANTED: (B)(6) 2002. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM (B)(6) MEDICAL EXAMINER WITH LIMITED INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY FIVE YEARS POST IMPLANT OF THE IPG SYSTEM. A CAUSE OF DEATH WAS REQUESTED AND REPORTED AS CARDIAC ARRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195881 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Death