BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922327 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12870
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 9, 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
    OR, 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) DISTAL CONDUCTOR FRACTURE (OVERSTRESS); THE FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED THAT THE DISTAL CONDUCTOR IS DISTORTED, THE OUTER INSULATION IS KINKED/BUCKLED, BLOOD IS IN/ON THE HELIX MECHANISM, THE LEAD STRETCHED, AND THE LEAD WAS DAMAGED AT IMPLANT. IT WAS NOTED THAT THE LEAD WAS RECEIVED WITH THE DISTAL COIL DISTORTED AND FRACTURED WITHIN THE CONNECTOR. AT THIS TIME IT ISN'T POSSIBLE TO TEST THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THE LEAD, THE FIXATION HELIX STOPPED EXTENDING AND RETRACTING. THE LEAD WAS REMOVED AND RETURNED. THERE WERE NO PATIENT COMPLICATIONS 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 Other