BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2203198 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11663
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, AND THERE WAS BLOOD IN/ON THE LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS. DURING THE IMPLANT ATTEMPT TO REPLACE THE LV LEAD, THE LEAD LOBES WERE DEPLOYED MULTIPLE TIMES IN TIGHT ANATOMY. AFTER MULTIPLE ATTEMPTS, THE LOBES WOULD NOT DEPLOY AS THE OUTER CASING WOULD ACCORDION ON ITSELF. THE LEAD WAS NOT IMPLANTED AND THE ORIGINAL LEAD WAS REPOSITIONED. 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 DTB MEDTRONIC PUERTO RICO, INC. 4195 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R 6947 IMPLANTABLE TACHY LEAD| (B)(4) TISSUE VALVE| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR