BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2130602 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10189
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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) AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED OVER TIME DUE TO PATIENT ACTIVITY AND WAS UNABLE TO REPOSITION THE LEAD TO ITS ORIGINAL POSITION DUE TO SCAR TISSUE THAT HAD FORMED AT THE ORIGIN OF THE VEIN. THEREFORE THE LV PORT ON THE DEVICE WAS PLUGGED AND CONVERTED FROM A BI-VENTRICULAR DEVICE TO A ICD DEVICE. 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 OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 6721L IMPLANTABLE TACHY LEAD| 6936 IMPLANTABLE TACHY LEAD| D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4068 IMPLANTABLE PACING LEAD| 4558M IMPLANTABLE PACING LEAD