BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2933873 · Received January 29, 2013

    Report

    Report Number
    2649622-2013-00055
    Event Type
    Death
    Date Received
    January 29, 2013
    Date of Event
    February 2, 2012
    Report Date
    February 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCT: 5554 IMPLANTABLE PACING LEAD, (B)(6) 2004. (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. IT WAS NOTED THAT ONLY VISUAL ANALYSIS ONLY WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. 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 AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURER'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT OF THE IPG SYSTEM. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38544 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)