BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1990337 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01940
    Event Type
    Injury
    Date Received
    February 15, 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
    OH, 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): NO ANOMALIES FOUND, FULL LEAD WAS RETURNED. IT WAS ALSO NOTED THAT THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION AND THERE WAS APPARENT EXPLANT DAMAGE. BLOOD/BODY FLUID WAS ALSO NOTED ON THE HELIX MECHANISM AND THE PROXIMAL CONDUCTOR. (B)(4): NO ANOMALIES FOUND. (B)(4): NO ANOMALIES FOUND, FULL LEAD WAS RETURNED. IT WAS ALSO NOTED THAT THE INNER INSULATION WAS KINKED BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING ON THE OUTER TUBING OVERLAY AND THERE WAS APPARENT EXPLANT DAMAGE. BLOOD WAS ALSO NOTED ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPSIS WITH VEGATATION ON THE LEAD. THE DEVICE AND LEADS WERE REMOVED. NO FURTHER 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 64 YR Hospitalization| R