Information was received from a medsun report via an unknown source regarding a patient receiving baclofen (unknown concentration at 109 mcg/day) via an implantable infusion pump.It was reported that approximately six years ago, the patient with a diagnosis of increasing spasticity had an implantable programmable infusion pump placement for drug delivery of baclofen.Earlier this month ((b)(6) 2017), the patient underwent mri studies and the pump began to alarm approximately one hour after the customer had arrived back home.The warning beep continued through the day.The patient contacted the physician and withdrawal symptoms were covered by oral baclofen.Unfortunately, the patient did begin to experience more spasticity because of the change in baclofen administration.The patient and physician arranged to meet at that facility.The physician noted that interrogation of the customer's pump revealed that there was a motor stall at the time of the mri, but it also showed that there was a battery failure.The customer's dose was reduced from 109 mcg/day to 3 mcg/day per settings of the pump.There were several interrogations to be certain that was the case.The physician contacted technical support and reviewed the findings on the programmer.While the pump was coming near the end of its useful life, based on analysis of the baclofen pump logs, it appeared that the battery life should have lasted until at least the end of the current calendar year.The event caused the patient to develop increased spasticity.Oral dosing was not effective.Because of the failure, the patient required surgical replacement of the malfunctioning baclofen pump much sooner than anticipated.No further complications were reported.
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