BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1924021 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13336
    Event Type
    Malfunction
    Date Received
    December 14, 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
    TN, 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. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE LEAD STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. THE FULL LEAD WAS RETURNED AND ANALYZED. (B)(4): NO ANOMALIES WERE FOUND. HOWEVER THE PROXIMAL CONDUCTOR WAS DISTORTED. ALL CONDUCTORS HAD BLOOD/BODY FLUID AT THE ELECTRODE END (NOT OBSTRUCTED). THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID AT THE TIP TO RING SPACER (NOT OBSTRUCTED). THE LEAD WAS STRETCHED. THE LEAD HAD BEEN DAMAGED AT IMPLANT. THE ANALYST NOTED THAT BY DESIGN, LEFT HEART LEADS ARE MANUFACTURED WITH A SEPTUM IN THE TIP THAT WILL SOMETIMES ALLOW BLOOD INGRESS. THE FULL LEAD WAS RETURNED AND ANALYZED. (B)(4): NO ANOMALIES WERE FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT AND THE LEAD WAS STRETCHED. THE LEAD HAD BEEN DAMAGED AT IMPLANT. THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT MULTIPLE LEADS (4193, 4194, 4196) WERE ATTEMPTED. ALL LEADS WERE REPORTED TO HAVE HIGH THRESHOLDS THE 4193 AND 4194 WERE UNABLE TO BE POSITIONED DUE TO ANATOMY. IT WAS ALSO REPORTED THAT LEAD MODEL 4196 HAD A DEFECTIVE TIP SEAL. THE LEADS WERE NOT IMPLANTED AND A DIFFERENT 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 ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 5076 IMPLANTABLE PACING LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD