BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991977 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02664
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. BLOOD WAS ALSO NOTED ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER IMPLANT THE PHYSICIAN DISCOVERED THAT THE ATRIAL LEAD WAS DISLODGED. THE PHYSICIAN TRIED TO REPOSITION THE LEAD, BUT THE HELIX COULD NOT BE RETRACTED. THE PHYSICIAN THEN EXTRACTED THE LEAD. THE LEAD WAS TESTED ON THE TABLE AND THE HELIX WAS ABLE TO BE RETRACTED AFTER MANY TURNS AND VERY SUDDENLY. THE PHYSICIAN THEN DECIDED TO IMPLANT A NEW LEAD. 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 Hospitalization| R