MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Electromagnetic Interference (1194); Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (2000 mcg/ml at 97 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.It was reported that the patient had a vp (ventriculoperitoneal) shunt that was infected.On (b)(6) 2022 the neurosurgeon had gone in to remove the vp shunt however during the case realized that the patient also had a pump.The neurosurgeon wanted to remove the pump as well just to be safe, but they did not believe the pump was infected.They had weaned the patient¿s pump down and the plan was to remove the pump on (b)(6) 2022; however, the pump had a motor stall last night around 11 pm that lasted for 3.5 hours.The pump stalled again this morning around 8:30 am.It was confirmed that the patient did not have an mri.The patient was wearing something over his wrist that was used to check his other device which was a vagal nerve stimulator.The plan was to check the pump again later today to see if the stall recovered and if not, the hcp would be contacted so the hcp could provide oral baclofen for the patient in the meantime.
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Event Description
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Additional information was received that the motor stall was caused by the vagal nerve stimulator (vns) magnet that the nurse put on the patient's wrist directly over the pump.The patient's weight was asked but unknown.The device was sent to the hospital lab and discarded.
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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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