BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991411 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08125
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. A PROXIMAL PORTION OF THE LEAD WAS RECEIVED MEASURING 12.5 CM. A DISTAL PORTION OF THE LEAD WAS RECEIVED MEASURING 39.5 CM. PRIMARY ANALYSIS REVEALED THAT THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO. ADDITIONALLY, THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO A CUT AND THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO A CUT. PRODUCTS: 694965 IMPLANTABLE TACHY LEAD IMPLANTED: 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. THE RA LEAD WAS 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
    468813 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R (B)(4) ICD