BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2053579 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05939
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 28, 2011
    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
    ND, 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. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE PHYSICIAN ATTEMPTED TWO TIMES TO PLACE A RIGHT VENTRICULAR LEAD. THE FIRST LEAD COULD NOT BE PLACED IN THE DESIRED LOCATION. THE DOCTOR STATED THAT IT FELT AS IF THE WIRE WAS "STICKY OR HAVING LOTS OF RESISTANCE" AND LATER SAID THAT IT WAS AS IF THE "WIRE [WAS] TANGLED OR [DUE TO] PATIENT ANATOMY." THE IMPLANT ATTEMPT WITH THE SECOND LEAD HAD THE SAME RESULT. BOTH LEADS WERE NOT IMPLANTED AND ANOTHER LEAD WAS 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 ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other (B)(4) IMPLANTABLE PACING LEAD