BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2202046 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11267
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 5, 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
    MN, 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 AND ANALYZED, NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID ON OUTER TUBING OVERLAY, AND BLOOD IN/ON HELIX/LOBE MECHANISM. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED, NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYSTEM UPGRADE PROCEDURE BOTH THE 4195 AND 4196 LEADS WERE ATTEMPTED TO BE IMPLANTED, BUT WERE UNSUCCESSFUL DUE TO THE PATIENT'S ANATOMY. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. 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 76 YR Other 5076 IMPLANTABLE PACING LEAD| ADSR01 IMPLANTABLE PULSE GENERATOR