MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2023 |
Event Type
malfunction
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Event Description
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Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving unknown intrathecal baclofen via an implanted pump for intractable spasticity.It was reported the patient was in for a refill on the date of this report and had 410 mcg/day programmed with a concentration of 2,000 mcg/ml.It was reported 1,000 mcg/ml was in the pump.Technical services (tss) calculated the patient was receiving 205 mcg/day.It was confirmed that was what she wanted the patient to be receiving.The rep wanted to verify correct programming to keep the daily dose at 205 mcg/day.Tss verified drug concentration would change to 1,000 mcg/day and daily dose would change to 205 mcg/day.Tss also verified that because the concentration and daily dose were both halved, flow rate would remain the same and no bridge necessary.It was reported the patient did not have any symptoms of underdose/overdose.
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Manufacturer Narrative
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Continuation of d10: product id a810 lot# serial# unknown implanted: explanted: product type software section d information references the main component of the system.Other relevant device(s) are: product id: a810, serial/lot #: unknown, ubd: , udi#: 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.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 manufacturer's representative (rep).It was reported that the patient weight was asked, but the physician did not provide the requested information.The device software version was also asked, but the physician did not provide the requested information.The event was resolved.
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Manufacturer Narrative
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Continuation of d10: product id a810 serial# unknown product type software 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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