BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131013 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10350
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, ANALYZED, AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX FULLY RETRACTED. WHEN THE HELIX WAS RETRACTED DURING THE PROCEDURE, THE IS-1 CONNECTOR PIN WAS TURNED AN EXCESSIVE NUMBER OF TIMES RESULTING IN DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WERE NUMEROUS ATTEMPTS TO DEPLOY AND SECURE THE LEAD IN THE RIGHT VENTRICULAR APEX. THE LEAD WAS NOT USED AND ANOTHER 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 72 YR Other