BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2130975 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10330
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THAT THE OUTER INSULATION WAS BREACHED CUT. ALL CONDUCTORS WERE CUT AND THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION OF THE LEAD WAS DAMAGED DURING INITIAL ATTEMPT TO SLIT. THE LEAD WAS NOT USED AND ANOTHER WAS SUCCESSFULLY IMPLANTED. 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 ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD