BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2811420 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16117
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE LEAD IN SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE DISTAL END OF THE LEAD. BLOOD INGRESSION WAS OBSERVED ON THE LEAD INSULATION OVERLAY TUBING AND THE DISTAL LEAD CONDUCTOR HAD BLOOD (NOT OBSTRUCTED.) THE LEAD INSULATION HAD COSMETIC OUTER INSULATION CUT AND THE LEAD HAD DAMAGE AT IMPLANT. THE LEAD WAS RECEIVED WITH THE LOBES DISTORTED AND PARTIALLY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN COULD NOT PASS THE LEAD DOWN THE SHEATH. SEVERAL WERE ATTEMPTED, AND THE PHYSICIAN COMPLAINED THAT THE SHEATH IS TOO DIFFICULT TO OPERATE. DURING THE IMPLANTATION OF THE LEAD, THE LOBE OF THE LEAD OPENED DURING PLACEMENT AND COULD NOT PASS DOWN THE VEIN. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN COULD NOT PASS THE LEAD DOWN THE SHEATH. SEVERAL WERE ATTEMPTED, AND THE PHYSICIAN COMPLAINED THAT THE SHEATH IS TOO DIFFICULT TO OPERATE. DURING THE IMPLANTATION OF THE LEAD, THE LOBE OF THE LEAD OPENED DURING PLACEMENT AND COULD NOT PASS DOWN THE VEIN. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 6208X3 PERMANENT LEAD INTRODUCERS