BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131247 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10629
    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
    CO, 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) A PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYSIS REVEALED THAT THE INNER INSULATION WAS BREACHED WITH METAL INDUCED OXIDATION. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED AND PULLED APART (OVERSTRESS). THE INNER AND OUTER INSULATION HAD COSMETIC METAL INDUCED OXIDATION. THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, A WHITE SUBSTANCE ON IT, AND A COSMETIC DEPRESSION. THE LEAD WAS STRETCHED. (B)(4) A PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYSIS REVEALED NO ANOMALIES. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT AND HAD A COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON HELIX/LOBE MECHANISM AND MECHANISM (SLEEVE HEAD) AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS BOTH HAD NO CAPTURE AND LEAD FRACTURES. BOTH LEADS 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
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR