BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1991878 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02601
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION WAS MELTED, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE STEROID RING AT THE TIP WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEFT VENTRICULAR LEAD COULD NOT BE PLACED BECAUSE THE PATIENT'S VESSEL WAS TOO THIN. IT WAS ALSO REPORTED THAT WHILE ATTEMPTING TO IMPLANT THE RIGHT ATRIAL LEAD, THE RESISTANCE AND THRESHOLD WERE CONSISTENTLY TOO HIGH. BOTH LEADS WERE NOT USED. 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 76 YR Other