BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1925154 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13725
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 3, 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
    MA, 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) NO ANOMALIES WERE FOUND, HOWEVER, ALL CONDUCTORS WERE STRETCHED AND THE LEAD WAS DAMAGED AT IMPLANT. THE FULL LEAD WAS RETURNED AND ANALYZED. THE ANALYST NOTED BY DESIGN, LEFT HEART LEADS ARE MANUFACTURED WITH A SEPTUM IN THE TIP THAT WILL ALLOW THE GUIDE WIRE TO GO THROUGH THE TIP ELECTRODE. TIP ELECTRODE IS DAMAGED. (B)(4) NO ANOMALIES WERE FOUND, HOWEVER BLOOD/BODY FLUID WAS NOTED ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY AND THE LOBE MECHANISM. THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF THE FIRST LEFT VENTRICULAR LEAD THE GUIDEWIRE PIERCED THROUGH THE INSULATION OF THE LEAD. THE LEAD WAS REMOVED. A SECOND LEAD WAS ATTEMPTED. IT WAS ALSO REPORTED THAT THE INNER CONDUCTOR COIL BEGAN TO UNRAVEL AS THE PHYSICIAN INSERTED THE GUIDEWIRE THROUGH THE DISTAL END. THIS LEAD WAS REMOVED. IT WAS ALSO REPORTED THAT ON THE THIRD ATTEMPTED LEAD THE LOBES KEPT DEPLOYING DURING THE IMPLANT MAKING IT IMPOSSIBLE TO POSITION THE LEAD. A FOURTH LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 Other