BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951575 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00130
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY:THE FULL LEAD WAS ANALYZED AND THE OUTER INSULATION WAS FOUND TO HAVE A BREACH DEPRESSION. BLOOD/BODY FLUID WAS NOTED ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), BLOOD WAS NOTED IN/ON THE HELIX MECHANISM AND A COSMETIC DEPRESSION WAS NOTED ON THE OUTER INSULATION. (B)(4).

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED ELECTIVELY AS PART OF AN UPGRADE FROM SINGLE CHAMBER TO DUAL CHAMBER THERAPY.THE LEAD WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS ARESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57466 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R SESR01 IMPLANTABLE PULSE GENERATOR