BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6214888 · Received December 29, 2016

    Report

    Report Number
    2649622-2016-16459
    Event Type
    Death
    Date Received
    December 29, 2016
    Date of Event
    December 22, 2016
    Report Date
    December 22, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 5568-53, LEAD, IMPLANTED: (B)(6) 2008. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S SYSTEM WAS REPLACED DUE TO POCKET INFECTION. DURING THE REPLACEMENT PROCEDURE, LASER WAS USED TO EXTRACT THE LEADS. WHILE EXTRACTING THE LEADS, SUPERIOR VENA CAVA (SVC) WAS DISSECTED AT THE SVC-ATRIAL JUNCTION. THE PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862870 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death (B)(4) IPG