BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2131202 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10619
    Event Type
    Malfunction
    Date Received
    June 16, 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
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ELEVATED LEAD THRESHOLDS. THE LEADS REMAIN IN USE. 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 70 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076-1 IMPLANTABLE PACING LEAD| 4076-2 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5866-38M IMPLANTABLE LEAD ADAPTOR