BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1991928 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02636
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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): 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 BY DESIGN, LEFT HEART LEADS ARE MANUFACTURED WITH A SEPTUM IN THE TIP THAT WILL SOMETIMES ALLOW BLOOD INGRESS. IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYSTEM UPGRADE, A LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED BUT WAS UNABLE TO BE PLACED IN THE VESSEL WITH AN ACCEPTABLE THRESHOLD. THE LEAD WAS NOT IMPLANTED AND A SECOND LV LEAD WAS ATTEMPTED. THIS LV LEAD HAD UNACCEPTABLE THRESHOLDS WITH NO PACING CAPTURE. IT WAS ALSO NOTED THAT THIS LEAD HAD A LARGE AMOUNT OF BLOOD INGRESS. THE LEAD WAS NOT IMPLANTED AND A THIRD LV LEAD WAS ATTEMPTED. THIS LV LEAD WAS PLACED, THE INCISION WAS CLOSED AND THEN IT WAS NOTED ON FINAL CHECK THAT THE LEAD HAD DISLODGED. IT WAS ALSO NOTED WITH THE FINAL CHECK THAT THE PREVIOUSLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD HAD RETRACTED AS WELL SO THERE WAS MINIMAL SLACK. THE INCISION WAS REOPENED AND THE LV LEAD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS READVANCED AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R