BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1874703 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11508
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 NO ANOMALIES WERE FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID AND THE OUTER INSULATION MELTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH/UNSTABLE/UNMEASURABLE THRESHOLDS ON THE LEAD. THE LEAD WAS REMOVED. 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. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD