BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1991663 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02486
    Event Type
    Injury
    Date Received
    February 15, 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
    MO, 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 IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD DETECTED NOISE AND HAD HIGH IMPEDANCE, AN APPARENT FRACTURE AND WAS OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. THE LEFT VENTRICULAR LEAD WAS ALLEGED TO HAVE A MALFUNCTION AND HIGH IMPENDENCE. THE LEAD IS STILL 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 OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD