BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1920950 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12353
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 1, 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
    OH, 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 NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM. THE ANALYST COMMENTED THAT THE HELIX EXTENDS AND RETRACTS WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, AFTER THE LEAD WAS PLACED IN THE RIGHT VENTRICLE, THE HELIX WOULD NOT EXTEND. IT WAS ALSO REPORTED THAT WHEN THE LEAD WAS TAKEN OUT OF THE BODY, IT TOOK 35 TURNS TO GET THE HELIX TO EXTEND. THE LEAD WAS NOT 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 73 YR Other (B)(4) STENT GRAFT| (B)(4) STENT GRAFT| (B)(4) STENT GRAFT