BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1861814 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10085
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR DISTORTED; FULL LEAD WAS RETURNED AND ANALYZED. THE HELIX WILL NOT EXTEND AND A STYLET CAN NOT BE INSERTED INTO THE LEAD DUE TO DISTORTED COIL IN THE CONNECTOR. DEFORMATION/FRACTURE IN 5CM PROXIMAL SECTION OF THE INNER COIL AND EXTENSION PROBLEMS. BLOOD IN/ON HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "STEEL WIRE" COULD NOT BE INTRODUCED IN THE LEAD. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 79 YR Required Intervention