BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2921310 · Received January 17, 2013

    Report

    Report Number
    2649622-2013-00040
    Event Type
    Death
    Date Received
    January 17, 2013
    Date of Event
    December 14, 2012
    Report Date
    February 4, 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

    A CAUSE OF DEATH WAS RECEIVED FROM THE FUNERAL HOME AS LUNG CANCER WITH METASTASES TO THE BONE. PRODUCT EVENT SUMMARY: (B)(4)-THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. A VISUAL ANALYSIS WAS 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 PROCESS; NO INFORMATION HAS BEEN RECEIVED, SHOULD THE REQUESTED ADDITIONAL INFORMATION BE SUBSEQUENTLY RECEIVED IT WILL BE PROCESS AND CONSIDERED ACCORDINGLY. A CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: DEVICE EVALUATED BY MFR?: NO, EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A SINGLE CHAMBER 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 DIED APPROXIMATELY SIX MONTHS POST THE IPG IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25880 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death (B)(4) IMPLANTABLE PULSE GENERATOR