BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2864262 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17495
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    October 14, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Adverse Event
    Yes
    Product Problem
    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. PRODUCT EVENT SUMMARY (B)(4): THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION HAD METAL ION OXIDATION. IT WAS NOTED THERE WAS BLOOD ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED). (B)(4). CONCOMITANT PRODUCT: (B)(4) IMPLANTABLE PULSE GENERATOR (B)(6) 2011.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. THE LEADS WERE ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT IS DECEASED. ADDITIONAL INFORMATION OBTAINED NOTED THE PATIENT DIED OF ACUTE RESPIRATORY FAILURE AND ACUTE ENDOCARDITIS. INFORMATION OBTAINED FROM THE CLINIC NOTED THAT THE PATIENT HAD SUSTAINED A FALL THREE MONTHS PRIOR TO PATIENT DEATH AND HAD BRUISING BEHIND BOTH EARS. THE DEVICE WAS CHECKED AND REVEALED NORMAL DEVICE FUNCTION. ADDITIONAL INFORMATION RELATED TO THE CIRCUMSTANCES OF PATIENT DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death 4092 IMPLANTABLE PACING LEAD