BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1792656 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07055
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. THE FULL LEAD WAS RETURNED FOR ANALYSIS AND IT WAS FOUND THAT THE HELIX EXTENDED AND RETRACTED WITHIN THE PRODUCT SPECIFICATIONS. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE THAT AS THE PHYSICIAN WAS CHECKING THE LEAD PRIOR TO THE IMPLANT ATTEMPT THAT THE HELIX WOULD NOT EXTEND PROPERLY. THE LEAD WAS NOT IMPLANTED AND THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT.

    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 Required Intervention