BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922652 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13019
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    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 AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD WAS ON THE HELIX MECHANISM. THE HELIX EXTENDS AND RETRACTS WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD WAS ADVANCED TO THE RIGHT VENTRICULAR APEX AND INITIAL IMPEDANCE WAS HIGH WITHOUT EXTENDING THE HELIX. THE SIGNAL LOOKED NORMAL, SO HELIX EXTENSION WAS ATTEMPTED. THE HELIX WOULD NOT EXTEND IN VIVO. THE LEAD WAS REMOVED FROM THE PATIENT AND TESTED ON THE TABLE, BUT THE HELIX WOULD STILL NOT EXTEND. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other