BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3110571 · Received May 14, 2013

    Report

    Report Number
    2649622-2013-05398
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    June 9, 2011
    Report Date
    May 31, 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 SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. (B)(4). ADDR01 IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2010; 5076-52 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2010.

    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 TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ELEVEN MONTHS AFTER DEVICE SYSTEM IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ELEVEN MONTHS AFTER DEVICE SYSTEM IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212283 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Death