BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2914037 · Received January 14, 2013

    Report

    Report Number
    2649622-2013-00032
    Event Type
    Death
    Date Received
    January 14, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PROCESS AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCT: 5554 IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4). THE LEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT DEATH WAS REPORTED BY A FAMILY MEMBER WITH NO FURTHER INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY THREE DAYS 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
    21358 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)