BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811824 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16879
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    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. EVALUATION SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION WAS MELTED AND EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING. BLOOD/BODY FLUID WAS FOUND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), AND BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM. THE LEAD EXHIBITED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION OF THE RIGHT ATRIAL LEAD FOR POOR SENSING AND HIGH THRESHOLDS, THE PHYSICIAN SAW BLOOD INSIDE THE LEAD AND SUSPECTED A CRACK IN THE INSULATION. THE LEAD HAD BEEN MANIPULATED DURING A PRIOR DEVICE UPGRADE PROCEDURE AND THE LEAD SLACK HAD BEEN PULLED BACK ACCIDENTALLY. THIS WAS SUSPECTED TO HAVE COMPROMISED THE PERFORMANCE OF THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 4396 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD| D314TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB