BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 1792487 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07117
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    April 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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): OUTER TUBING OVERLAY PULLED APART (OVERSTRESS), HELIX DISTORTED/BENT, AND DAMAGED AT IMPLANT; THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE RETENTION SLEEVE PULLED AWAY FROM THE OVERLAY TUBING. THERE IS EVIDENCE OF ADHESIVE BONDED ON THE DISTAL END OF THE RETENTION SLEEVE; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE THAT IT WAS DIFFICULT TO DEPLOY THE LOBES OF THE LEAD. ONCE THEY WERE DEPLOYED, IT WAS NOT POSSIBLE TO KEEP THEM DEPLOYED, DESPITE HAVING THE TOOL IN THE CORRECT POSITION. THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S STATUS WAS REPORTED AS "OK".

    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 Required Intervention