BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2131094 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10384
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 29, 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
    IN, 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND ALL CONDUCTORS WERE DISTORTED. IT WAS NOTED THAT ALL CONDUCTORS HAD A RESIDUE LEFT BEHIND, THE GUIDEWIRE WAS STUCK IN THE LEAD AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THERE IS A SLIGHT DISTORTION OF THE CONDUCTORS AT 7 CM. THERE IS A SMALL AMOUNT OF GREEN RESIDUE LEFT BEHIND IN THE CONDUCTORS FROM THE COATING ON THE COMPETITOR GUIDEWIRE. THE WIRE WAS STUCK IN THE LEAD WHEN RETURNED DUE TO DISTORTION AT 7 CM, THE WIRE WAS ABLE TO BE REMOVED AND INSERTION TEST PASSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE LEFT VENTRICULAR LEAD AFTER SLITTING. THERE MAY HAVE ALSO BEEN A "PINCHING" OF THE LEAD AT THE SUBCLAVIAN VEIN AREA. THE LEAD AND GUIDEWIRE WERE REMOVED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. 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 83 YR Other