BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 2810695 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15779
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 6, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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; ANALYSIS REVEALED A BREACHED CUT OF THE OUTER INSULATION. THE LEAD WAS ALSO DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE IMPLANTATION OF THE LEFT VENTRICULAR [LV] LEAD, THE PHYSICIAN NOTICED A TEAR IN THE PROXIMAL WHITE TENSION/SECURING BAND OF THE LEAD. IT WAS ALSO REPORTED THAT THE TEAR MAY HAVE BEEN CAUSED BY "ROUGH HANDLING" OF THE LEAD WHILE THE LOBES WERE BEING EXERCISED. AN LV LEAD WAS NOT IMPLANTED AS THE PATIENT HAD "EXTREMELY DIFFICULT" ANATOMY. 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 OJX MEDTRONIC PUERTO RICO, INC. 4195

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other