BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2053505 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05919
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FOR ANALYSIS. UPON ANALYSIS IT WAS REPORTED THAT THERE WERE NO ANOMALIES FOUND. IT WAS NOTED THAT THE LEAD WAS RECEIVED WITH THE LOBES DEPLOYED WITH DRIED BLOOD ON THEM. DUE TO DRIED BLOOD UNDER THE OVERLAY TUBING AND ON THE LOBES, IT CANNOT BE DETERMINED AT THIS TIME WHAT CAUSED THE REPORTED DEPLOYMENT ISSUE. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE OUTER TUBING OVERLAY AND THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THERE WAS DIFFICULTY POSITIONING/FIXING THE LEAD AND THE LOBES WOULD NOT "UNDEPLOY ONCE TAKEN OUT OF THE SHEATH". THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN STARFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4195 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other