BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813063 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16237
    Event Type
    Injury
    Date Received
    October 31, 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
    CA, 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 IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION AS BREACHED (CLAVICLE-RIB CRUSH), THE OUTER INSULATION WAS MELTED, OUTER INSULATION HAD COSMETIC MIO , THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED, ALL CONDUCTORS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), ALL INSULATORS BREACHED (CLAVICLE-RIB CRUSH), THE OUTER INSULATION WAS MELTED, OUTER INSULATION HAD COSMETIC MIO , THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED AS WELL AS A POSSIBLE RIGHT VENTRICULAR LEAD FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR