BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791199 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14210
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE HELIX WAS DISTORTED/BENT, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX EXTENDED. THE HELIX EXTENDS AND RETRACTS SMOOTHLY AND WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING PRIOR TO IMPLANT, THE LEAD HELIX DID NOT EXTEND WITH THE MAXIMUM NUMBER OF REVOLUTIONS. WHILE THE PHYSICIAN WAS EXAMINING THE LEAD, THE HELIX SUDDENLY POPPED OUT. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 Other