A report was made by a healthcare provider to (b)(6) regarding an alleged malfunction of a medstream implantable infusion pump in a patient.It was reported to bfarm that there was "excessive delivery of a drug (baclofen) of unclear origin by an implanted drug pump codman medstream.Due to a massive overdose in the following days, the patient required ventilation (danger to life) (lz ventilation with tracheostomy).As a result, pneumonia develops." no additional information was provided with the bfarm report.Intera reached out to the healthcare provider and received the following information: the patient was being treated for spastic tetraplegia from c5 after c5/5 fracture, and was being treated with baclofen in the pump.Baclofen was dosed at 200 micrograms/day.The previous refill occurred on (b)(6) 2021.The patient experienced drowsiness, weakness, difficulty concentrating, had loss of consciousness within 2 days, hallucinations, respiratory failure.Interventions taken included neurological intensive care, ventilation.Current condition of the patient is alert, responsive, oriented, physically still weak with pronounced concentration disorders.The healthcare provider stated that there were no error codes displayed on the pump controller.Pump was reported to be explanted on (b)(6) 2021.The pump was reported not to have visible damage other than scratches on the surface due to the explant procedure.The healthcare provider stated the pump transaction logs were available but has not forwarded them to intera on request at the time of this report.The status of the explanted pump is not known at the time of this report.
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