MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Material Integrity Problem (2978); Insufficient Information (3190)
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Patient Problems
Muscular Rigidity (1968); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/25/2022 |
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) regarding a patient receiving baclofen via an implanted pump.The indication for pump use was multiple sclerosis and intractable spasticity.It was reported that the hcp believed that the patient¿s pump was not working.Per the hcp, the patient was not getting good therapy and they were looking at replacing the pump.
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Manufacturer Narrative
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Continuation of d10: product id 8784 lot# serial# (b)(6) implanted: explanted: product type catheter product id 8780 lot# serial# (b)(6) implanted: explanted: product type catheter 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 received from a company representative (rep) reported that the patient stated that they first started noticing symptoms of their pump not working the night of (b)(6) 2022.Symptoms include stiffness in legs.There were no known factors that may have led or contributed to the issue.The patient had a dye study done at one point by an interventional radiologist who determined that the catheter was fractured around l3 as well as possibly at the pump connection site.The patient was referred for a catheter replacement surgery.The issue was resolved at the time of report.The patient's weight and medical history was asked and will not be made available.The patient's status at the time of report was alive - no injury.
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Search Alerts/Recalls
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