BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152612 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06748
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THERE WAS ALSO BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LV (LEFT VENTRICULAR) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE INNER AND OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR. THE OUTER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE OUTER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. ANALYST COMMENTED THE LEAD WAS RETURNED WITH SEVERE EXPLANT DAMAGE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 694765, IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2004; D224DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POOR SENSING AND HIGH THRESHOLD ON THE RIGHT ATRIAL LEAD. DURING THE EXTRACTION OF THE ATRIAL LEAD, THE RIGHT VENTRICULAR (RV) LEAD INSULATION AND SUPERIOR VENA CAVA (SVC) COIL WERE COMPROMISED. BOTH LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252118 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R