BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3031539 · Received April 2, 2013

    Report

    Report Number
    2649622-2013-02589
    Event Type
    Death
    Date Received
    April 2, 2013
    Date of Event
    March 2, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID D354TRG, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT ID 693565, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT ID 439688, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  SYSTEM AND THE NEXT DAY EXPIRED IN THE HOSPITAL DUE TO VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). THE STRIPS FROM THE MONITOR SHOWED A SLOW VENTRICULAR TACHYCARDIA (VT) UNDER THE DETECTION ZONE. THE CONCERN IS ABOUT WHY THE PATIENT DID NOT GET SHOCKED FOR THE VENTRICULAR FIBRILLATION (VF) AND WHY PACING DID NOT HAPPEN. THE CUSTOMER ALLEGES THAT A POSSIBLE DEVICE MALFUNCTION LED TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135263 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death