BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1922431 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12926
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. IT WAS 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. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL LEADS WERE ATTEMPTED TO BE IMPLANTED IN THE PATIENT'S LEFT VENTRICLE (LV) BUT WERE NOT RETAINED DUE TO HIGH THRESHOLDS, STIMULATION AND THE PATIENT'S ANATOMY. A LEFT VENTRICULAR LEAD WAS NOT IMPLANTED IN THIS PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 79 YR Other 6949 IMPLANTABLE TACHY LEAD| 4568 IMPLANTABLE PACING LEAD| D153ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4074 IMPLANTABLE PACING LEAD