BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3013835 · Received March 20, 2013

    Report

    Report Number
    2649622-2013-02541
    Event Type
    Death
    Date Received
    March 20, 2013
    Date of Event
    February 5, 2012
    Report Date
    April 26, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOLLOW-UP IS IN PROGRESS. THE DECISION TO REPORT WAS DETERMINED BASED ON INFORMATION THAT WAS AVAILABLE AT THE TIME OF DECISION. SHOULD ADDITIONAL INFORMATION BECOME KNOWN THROUGH FOLLOW-UP, IT WILL BE ADDED TO THE EVENT AND PROCESSED ACCORDINGLY. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED. CONCOMITANT PRODUCT: (B)(4) IMPLANTABLE PULSE GENERATOR 2011 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN PERSON WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY FIVE MONTHS POST THE IPG SYSTEM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115486 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death 383059 IMPLANTABLE PACING LEAD