BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1926348 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14295
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 14, 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
    VA, 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) UPON ANALYSIS OF THE FULL LEAD IT WAS REPORTED THAT THERE WERE NO ANOMALIES FOUND, THE INNER INSULATION WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS STRETCHED. ANALYSIS ALSO REVEALED THAT THE HELIX EXTENDS AND RETRACTS WITHIN PRODUCT SPECIFICATION. IT WAS APPARENT THAT DAMAGE OCCURRED DURING IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THERE WAS HIGH, UNSTABLE, AND/OR VARIABLE THRESHOLDS ON THE RIGHT VENTRICULAR LEAD. AFTER MULTIPLE ATTEMPTS TO REPOSITION THE LEAD, THERE WAS DIFFICULTY EXTENDING AND RETRACTING THE HELIX. THE LEAD WAS NOT IMPLANTED 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 81 YR Other