Description of Event or Problem · 0
IT WAS REPORTED IN AN ARTICLE (SAYER, C., LUMSDEN, D.E., PERIDES, S., TUSTIN, K., BASSI, S., LIN, J-P., KAMINSKA, M. INTRATHECAL BACLOFEN TRIALS: COMPLICATIONS AND POSITIVE YIELD IN A PEDIATRIC COHORT. JOURNAL OF NEUROSURGERY. PEDIATRICS. 2015:1-6. DOI: 10.3171/2015.5.PEDS14587.) THAT THREE PATIENTS IN THE CATHETER TRIAL EXPERIENCED BACK PAIN. NINE TRIAL PATIENTS (7 CATHETER AND 2 LP) EXPERIENCED VOMITING. ONE PATIENT IN THE CATHETER TRIAL EXPERIENCED DEHYDRATION. FOUR PATIENTS IN THE CATHETER TRIAL EXPERIENCED CSF LEAK. ONE CATHETER WAS REMOVED DUE TO EXCESSIVE CSF LEAKAGE AND THE TRIAL WAS NOT REATTEMPTED AT PARENTAL REQUEST. THREE PATIENTS (2 CATHETER AND 1 LP) EXPERIENCED INFECTION. FOR 2 OF THE POTENTIAL INFECTIONS, SHORT-LASTING PYREXIA ALONE WAS REPORTED, WHICH MIGHT RELATE TO OTHER ASPECTS OF THE HOSPITAL STAY THAT EXPOSED OUR PATIENTS TO POTENTIAL INFECTIONS. ONE PATIENT IN THE CATHETER TRIAL EXPERIENCED MENINGITIS. THE PATIENT DEVELOPED SYMPTOMS OF MENINGITIS (FEVER, HEADACHE, VOMITING, PHOTOPHOBIA, AND NECK STIFFNESS) WITHIN 24 HOURS OF CATHETER REMOVAL. THE TIP OF THE CATHETER IS ROUTINELY SENT TO THE MICROBIOLOGY DEPARTMENT FOR TESTING AND IN THIS CASE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS FOR 14 DAYS ACCORDING TO SENSITIVITY AND MADE A FULL RECOVERY. ALTHOUGH THE TRIAL HAD BEEN POSITIVE, THIS COMPLICATION DISCOURAGED THE PATIENT'S PARENTS FROM PURSUING THE ITB PUMP. ONE PATIENT IN THE CATHETER TRIAL EXPERIENCED DIZZINESS. ONE PATIENT IN THE CATHETER TRIAL EXPERIENCED DROWSINESS. THREE PATIENTS IN THE CATHETER GROUP EXPERIENCED HEADACHE. TWO PATIENTS IN THE CATHETER GROUP EXPERIENCED DEEP SEDATION. TWO PATIENTS IN THE CATHETER GROUP EXPERIENCED WORSENED DYSTONIA PRIOR TO AND SHORTLY AFTER THE TRIAL. WE BELIEVE THIS DETERIORATION WAS RELATED TO DISCOMFORT CAUSED BY THE PRESENCE OF A SPINAL CATHETER. IN BOTH CASES, REDUCTION IN TONE AND DYSTONIC SPASMS WAS OBSERVED FOLLOWING ADMINISTRATION OF THE BACLOFEN TEST DOSE. ONE PATIENT IN THE LP GROUP EXPERIENCED HYPOTENSION. THERE WAS ALSO SEDATION. IT WAS SHORT-LIVED WITH NO RESPIRATORY COMPROMISE. IN ONE PATIENT THE CATHETER WAS REMOVED PRIOR TO USE. TWO PATIENTS EXPERIENCED CATHETER DISPLACEMENT PRIOR TO THE START OF THE TRIAL. THESE WERE CONVERTED TO SUCCESSFUL LP TRIALS. IN THREE PATIENTS, CATHETER PLACEMENT FAILED. PLACEMENT WAS SUCCESSFUL UNDER RADIOGRAPHIC GUIDANCE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).