BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131879 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10690
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HAD A BREACHED DEPRESSION, COSMETIC DEPRESSION, A WHITE SUBSTANCE, AND WAS MELTED. THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE OUTER INSULATION HAD A BREACHED DEPRESSION, A COSMETIC DEPRESSION, A BREACHED CUT, A WHITE SUBSTANCE, AND WAS MELTED. ALL CONDUCTORS WERE DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE INNER INSULATION WAS KINKED/BUCKLED. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE RECORDED ON THE RIGHT ATRIAL LEAD, NOISE ON THE RIGHT ATRIAL ELECTROGRAM (EGM) AND APPARENT FRACTURE DUE TO A SUBCLAVIAN CRUSH. THE RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO MEDICAL JUDGEMENT/SYSTEM UPGRADE. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R E2DR01 IMPLANTABLE PULSE GENERATOR