BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3021178 · Received March 26, 2013

    Report

    Report Number
    2649622-2013-02569
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ADDITIONAL INFORMATION FROM DEVICE INTERROGATION RECEIVED INDICATES THE PATIENT HAD A "POLYMORPHIC" VENTRICULAR TACHYCARDIA (VT) "WHICH HAD INTERVALS WITHIN" THE VENTRICULAR FIBRILLATION (VF) ZONE, BUT DID NOT MEET THE VF DETECTION CRITERIA; THE DEVICE HAD A PROGRAMMED VF ZONE WITH A VT MONITORING ZONE. THE CAUSE OF DEATH IS UNKNOWN. CONCOMITANT PRODUCTS: PRODUCT ID D354TRG, IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, IMPLANTED: (B)(6) 2012; PRODUCT ID 693565, IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2012; PRODUCT ID 419488, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012. (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.

    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 A PATIENT PARTICIPANT IN THE (B)(6) TRIAL IS DECEASED. THE PATIENT WAS FOUND DEAD IN BED BY THE SPOUSE. FURTHER REVIEW OF THE INFORMATION INDICATES THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST DEVICE SYSTEM IMPLANT. THERE ARE NO KNOWN DEVICE SYSTEM ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123459 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death