MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ambulation Difficulties (2544); Insufficient Information (4580)
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Event Date 03/11/2021 |
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) regarding a patient receiving bupivacaine (19 mg/ml at 10.417 mg/day), pri alt/ziconotide (2 mcg/ml at 1.0966 mcg/day), and sufenta/sufentanil (375 mcg/ml at 205.61 mcg/day) via an implanted pump.The indication for pump use was lumbar laminectomy syndrome and non-malignant pain.The hcp reported that they did a pump refill on the patient yesterday and he didn't seem himself.He was in a wheelchair and normally he was not.Per the hcp, the patient said he had several mris recently.The hcp didn't know if the mris were related to the patient¿s pump or therapy.The patient was in the hospital now and was having withdrawal symptoms.The hcp stated that they checked the logs and they did not see any evidence of a motor stall since november.It was reviewed that it was possible for a patient to have an mri and the pump not to stall.Per the hcp, they expected 5.2 ml and aspirated 5.5 ml at yesterday¿s refill.Assessing the catheter was discussed.
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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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Event Description
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Additional information was received from the healthcare provider (hcp).Regarding the patient's symptoms, it was unknown if there was an infusion system related device issue, patient/therapy issue, or procedural issue.It was indicated the cause of the issue was unknown.The patient had been refilled.The hcp was having the compounded medication screened to determine its potency.The test was still in-progress and it was noted the facility did not have a method for testing ziconitide for potency.
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Search Alerts/Recalls
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