BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1680885 · Received May 10, 2010

    Report

    Report Number
    1221611-2010-00004
    Event Type
    Other
    Date Received
    May 10, 2010
    Report Date
    April 15, 2010
    Manufacturer
    ASPECT MEDICAL SYSTEMS
    Product Code
    GWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON LEARNING OF THE POTENTIAL CASE OF AWARENESS, ASPECT PROMPTLY CONTACTED THE REPORTING PHYSICIAN, TO DETERMINE THE FOLLOWING INFO: THE MODEL AND SERIAL NUMBERS OF THE BIS MONITORING DEVICES USED TO MONITOR THE PT DURING THE REPORTED PROCEDURE. ACCESS TO THE MONITOR USED DURING THE PROCEDURE TO RETRIEVE THE RESTORED MEMORY FILES ASSOCIATED WITH THIS PROCEDURE. A DE-IDENTIFIED COPY OF THE COMPLETE ANESTHESIA RECORD FOR THE PROCEDURE. THE DATE, START TIME AND END TIME FOR THE PROCEDURE IN ORDER TO LOCATE THE APPROPRIATE DATA FILES WITHIN THE MONITOR. DEVICE LABELING STATES CLINICAL JUDGMENT SHOULD ALWAYS BE USED WHEN INTERPRETING THE BIS IN CONJUNCTION WITH OTHER AVAILABLE CLINICAL SIGNS. RELIANCE ON THE BIS ALONE FOR INTRAOPERATIVE ANESTHETIC MANAGEMENT IS NOT RECOMMENDED. AT THIS TIME, NO RESPONSE TO THE REQUEST FOR ADD'L INFO HAS BEEN RECEIVED. IT IS ALSO UNK IF THE DEVICE MALFUNCTIONED DUE TO THE DEVICE NOT BEING AVAILABLE FOR INSPECTION BY THE MFR. OUR INVESTIGATION CURRENTLY CONCLUDES THAT BIS MONITORING DID NOT CAUSE OR CONTRIBUTE TO A DEATH. BASED ONLY UPON THE REPORTING PHYSICIAN'S NARRATIVE, IT APPEARS THAT THE BIS MONITORING DEVICE CONTRIBUTED TO A POTENTIALLY SERIOUS INJURY. ASPECT BELIEVES IT WOULD BE PRUDENT TO SUBMIT THIS INITIAL REPORT PENDING THE RECEIPT OF ADD'L INFO.

    Description of Event or Problem · 1

    ASPECT MEDICAL SYSTEMS WAS INFORMED VIA RECEIPT OF A LETTER ON (B)(6) 2010 ABOUT A CASE OF POSSIBLE INTRAOPERATIVE AWARENESS. ACCORDING TO THE REPORTING PHYSICIAN, A (B)(6), WOMAN, UNDERWENT A TWO STAGE STABILIZATION PROCEDURE OF HER SPINE; THE FIRST PROCEDURE WAS UNEVENTFUL. TWO DAYS LATER THE PT UNDERWENT ANTERIOR SPINAL FUSION WITH THE SAME ANESTHETIC TEAM. IN VIEW OF LOW BIS VALUES AND HYPOTENSION REQUIRING TREATMENT WITH VASOACTIVE MEDICATION DURING THE FIRST PROCEDURE, THE PRACTITIONERS DECIDED TO DECREASE ANESTHETIC DOSES TO ACHIEVE BIS BETWEEN 40 AND 60 DURING THIS SURGERY IN ACCORDANCE WITH PUBLISHED RECOMMENDATIONS. SHE RECEIVED PROPOFOL AND REMIFENTANIL INFUSIONS, MOSTLY AT 30 AND 0.05 MCG/KG/MIN., RESPECTIVELY. ANESTHESIA WAS SUPPLEMENTED WITH INHALED DESFLURANE, AND BRIEFLY WITH NITROUS OXIDE; AGE-ADJUSTED MAC RANGED BETWEEN 0 AND 0.4 UNTIL NITROUS OXIDE. MEAN BIS VALUE (+ STANDARD DEVIATION) WAS 42 (+ 7). THE REPORTING PHYSICIAN DESCRIBED THAT THE PT INITIALLY COMPLAINED OF INTRAOPERATIVE RECALL UPON AWAKENING AFTER THE SURGERY. ONE MONTH FOLLOWING SURGERY, SHE DISCUSSED HER EXPERIENCE WHEN CONTACTED BY TELEPHONE, AND REPORTED VISUAL AND AUDITORY PERCEPTION, FEELING THE INITIAL SKIN INCISION AND OTHER PORTIONS OF SURGERY, AND THE INABILITY TO MOVE. SHE REPORTED EXPERIENCING PANIC, PROLONGED PAIN, HELPLESSNESS, AND FEAR. THE REPORTING PHYSICIAN'S NARRATIVE DID NOT INCLUDE ANY DESCRIPTION OF CURRENT STATUS OF THE PT, OR IF ANY TREATMENT HAD BEEN PROVIDED TO THE PT FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK GWQ ASPECT MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other