BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

    MDR report key: 1911242 · Received November 30, 2010

    Report

    Report Number
    2953769-2010-00587
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    BSP
    PMA / PMN Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED, FOLLOW UP WITH COMPANY REPRESENTATIVE. EMDR SUBMITTED (B)(6) AND ACK3 RECEIVED/FAILURE RECEIVED ON (B)(6). RESUBMITTED AFTER CORRECTING ERROR ON THE (B)(6). RE SUBMITTED ON (B)(6) AND RECEIVED ACK3 RECEIVED/FAILURE ON (B)(6). SINCE MEDTRONIC WAS CLOSED FOR THE HOLIDAY ON (B)(6). UPON RETURN TO THE OFFICE, WE NOTICED THIS FAILURE TODAY, (B)(6). THE EMDR WAS RESUBMITTED TODAY AND ANOTHER ACK3 RECEIVED/FAILURE WITH ANOTHER ERROR. UPON CORRECTION OF THIS ERROR, EMDR RESUBMITTED TODAY, (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN FAD PROCEDURE. BOTH CATHETERS WERE PLACED AND INFLATED AT LEVEL L4/L5. WHEN THE PROCEDURE WAS COMPLETED, THE FIRST CATHETER WAS REMOVED WITHOUT COMPLICATION. WHEN THE SECOND CATHETER WAS REMOVED, THE BALLOON HAD DESHEATHED AND REMAINED IN THE PATIENT. THE PHYSICIAN DID NOT REMOVE THE BALLOON FROM THE PATIENT. THERE ARE NO PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP MEDTRONIC SPINE LLC. ASKU 0003996769

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Other