MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
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Patient Problem
Muscular Rigidity (1968)
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Event Date 11/19/2023 |
Event Type
malfunction
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Event Description
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Information was received from a healthcare provider (hcp) regarding a patient receiving baclofen (2000 mcg/ml at 423 mcg/ml) via an implanted pump.The indication for pump use was cerebral palsy and intractable spasticity.The hcp reported that today she went to the patient¿s house one week early to refill the patient¿s pump.Per the hcp, 36 hours ago the patient began having increased muscle tone and spasticity.When she aspirated the reservoir, the pump was bone dry and no alarms had gone off.During the call, it was confirmed that the pump was programmed correctly at the last refill on 06-sep-2023 and that the pump should have reached low reservoir on 30-nov-2023; it was confirmed the patient had not undergone radiation, been exposed to temperatures hot enough to cause over infusion, etc; and it was also confirmed that the pump was both filled with 20 cc and programmed to 20 cc at the last refill.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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