BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 1926225 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14240
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 12, 2010
    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 AND ANALYZED. PRIMARY RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID FOUND ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), ON THE OUTER TUBING OVERLAY, AND IN/ON THE LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT, THE LEFT VENTRICULAR LEAD HAD A CAPTURE THRESHOLD OF GREATER THAN 8.0VOLTS. THE PHYSICIAN ATTEMPTED TO USE ANOTHER SMALLER CORONARY SINUS BRANCH, BUT THE LEAD WOULD NOT PASS INTO THE VESSEL. THE LEAD WAS REMOVED AND REPLACED. 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 76 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD