Description of Event or Problem · 1
PATIENT RECEIVED PLICATOR TREATMENT FOR GERD IN CONJUNCTION WITH THE PLICATOR SHAM STUDY. THE PLICATOR PROCEDURE WAS UNEVENTFUL; NO UNUSUAL EVENTS OCCURRED AT ANY TIME DURING THE PROCEDURE. UPON COMPLETING THE PROCEDURE, DR. FELT AS IF IT WERE HIS BEST PROCEDURE AND BEST LOOKING RESULT TO DATE. THE PATIENT COMPLAINED OF POST-PROCEDURAL EPIGASTRIC PAIN, WHICH BEGAN TO RADIATE TO THEIR LEFT SHOULDER. THEY WERE TREATED WITH DEMEROL 50 MG I.V., BUT THEIR PAIN WORSENED DURING THEIR POST-PROCEDURE RECOVERY PERIOD. THE PATIENT WAS ADMITTED TO HOSPITAL ON AN EVENING IN 05 WHERE THEY RECEIVED A CXR/ABDOMINAL SERIES AND PAIN MANAGEMENT. SIX DAYS LATER, THE PATIENT UNDERWENT AN EGD WHICH REVEALED AN INTACT WRAP OF THE GASTRIC TISSUE AND GOOD POSITION OF THE FOLD. THE PLICATOR IMPLANT WAS NOT VISIBLE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON ANALGESICS AND STEROIDS. ONCE HOME THE PATIENT BEGAN TO HAVE RECURRENCE OF THE PAIN DESPITE MEDICATIONS GIVEN TO CONTROL THIS. THEY WERE READMITTED TO HOSPITAL IN 5/05 WITH PAIN INVOLVING THE LEFT LUNG BASE AND EPIGASTRUM AND WERE DIAGNOSED WITH A LEFT PLEURAL EFFUSION. THEY WERE SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL FOUR DAYS LATER. SIX DAYS FOLLOWING DISCHARGE, THE PATIENT RETURNED TO THE DIGESTIVE HEALTH OFFICE WITH CONTINUING PAIN RADIATING TO THEIR LEFT SHOULDER AND REQUESTED REMOVAL OF THE PLICATION. LATER IN 2005 THE PATIENT WAS BROUGHT BACK INTO THE HOSPITAL, WITH THE INTENT OF ENDOSCOPICALLY REMOVING THE IMPLANT. UPON ENDOSCOPIC EXAMINATION, THE PLICATOR SUTURE WAS NOT VISIBLE, HOWEVER, TWO AREAS COULD BE IDENTIFIED THAT APPEARED TO BE WHERE THE PLICATOR PLEDGETS HAD BEEN. ATTEMPTS WERE MADE TO RETRIEVE THE PLICATOR IMPLANT BY EXPLORING THESE TWO AREAS WITH A GRASPER, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT THEN UNDERWENT LAPAROSCOPIC SURGERY DURING WHICH THE PLICATOR IMPLANT WAS REMOVED SUCCESSFULLY. THE PATIENT ALSO UNDERWENT A NISSEN FUNDOPLICATION AS PART OF THE LAP PROCEDURE. DURING THE SURGERY, INVOLVEMENT OF THE DIAPHRAGM WITH ADHESIONS WAS OBSERVED IN TWO LOCATIONS. THE PATIENT REPORTEDLY EXPERIENCED SIGNIFICANT POST SURGICAL PAIN. SEVEN DAYS FOLLOWING SURGERY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. TWO WEEKS LATER THE PATIENT RETURNED TO THE DIGESTIVE HEALTH OFFICE AND EVIDENCED SIGNIFICANT IMPROVEMENT. THEY CONTINUED TO REPORT MILD LEFT UPPER QUADRANT PAIN AND SOME PAIN AT THE SITE OF ONE OF THE TROCARS. AT THIS POINT, THE PATIENT IS CONTINUING THEIR RECOVERY FROM THE FUNDOPLICATION PROCEDURE. COMPANY IS CONSERVATIVELY INTERPRETING THE EXTENDED DURATION OF PAIN THAT REQUIRED SURGICAL INTERVENTION TO BE "MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT" AND THEREFORE A "SERIOUS INJURY" UNDER THE MDR REGULATIONS. IT SHOULD BE NOTED THAT EPIGASTRIC PAIN RADIATING TO THE LEFT SHOULDER HAS BEENB PREVIOUSLY REPORTED IN PLICATOR CLINICAL CASES AND IN OTHER ENDOLUMINAL GERD TREATMENT METHODS. THE PAIN ROUTINELY RESOLVES SPONTANEOUSLY OVER TIME IN SUCH CASES. IN THE REPORTED CASE, THE SURGICAL INTERVENTION WAS PERFORMED AT THE PATIENT'S REQUEST AND IT IS POSSIBLE THAT THEIR PAIN WOULD HAVE SPONTANEOUSLY SUBSIDED GIVEN MORE TIME.