BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3221631 · Received July 11, 2013

    Report

    Report Number
    2649622-2013-08200
    Event Type
    Death
    Date Received
    July 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCT: 5076-58 IMPLANTABLE PACING LEAD (B)(4), IMPLANTED: (B)(6) 2013, ADDR01 IMPLANTABLE PULSE GENERATOR (IPG), IMPL ANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM A MANUFACTURER REPRESENTATIVE. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATABASE/PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY 2 MONTHS POST IMPLANT OF THE IPG SYSTEM. PER THE FUNERAL HOME, THE CAUSES OF DEATH ARE LISTED AS 1) END STAGE RENAL FAILURE (ESRF) 2) ENDOCARDITIS 3) SICK SINUS SYNDROME. PER THE IMPLANT DOCTOR'S NURSE, THE DEVICE WAS EXPLANTED APPROXIMATELY 5 WEEKS AFTER IMPLANT BECAUSE THE PATIENT WAS FOUND TO HAVE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). SHE DID NOT KNOW WHERE THE MRSA WAS LOCATED. ALSO, AN ECHOCARDIOGRAM SHOWED RIGHT ATRIAL (RA) LEAD VEGETATION. AN EXTRACTION WITH POCKET DEBRIDEMENT WAS DONE TO DECREASE THE RISK OF CELLULITIS. THE PATIENT DIED APPROXIMATELY 3 WEEKS AFTER THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320767 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death