BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1923120 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13252
    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/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 NO ANOMALIES WERE FOUND. THERE WAS BLOOD IN/ON THE SLEEVEHEAD AND THE HELIX. (B)(4) THE FULL LEAD WAS RETURNED WHERE IT WAS DISCOVERED THAT THE DISTAL AND DEFIBRILLATION CONDUCTOR WERE DISTORTED. THERE WAS BLOOD IN/ON THE SLEEVEHEAD AND THE HELIX. THERE WAS BLOOD IN THE DISTAL CONDUCTOR NEAR THE LEAD ELECTRODE. THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, PHYSICIAN ATTEMPTED A LEAD IMPLANT IN THE RIGHT ATRIUM SEVERAL TIMES WITHOUT SUCCESS OF ATTACHMENT TO THE ATRIAL WALL. THE LEAD WAS REPLACED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED A LEAD IMPLANT IN THE RIGHT VENTRICLE SEVERAL TIMES, BUT AFTER SUCCESSFUL EXTENSION/RETRACTION OF THE ACTIVE FIXATION MECHANISM, IT WOULD NOT EXTEND. THE LEAD WAS REPLACED. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other