MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Decreased Respiratory Rate (2485); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2022 |
Event Type
Injury
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Event Description
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Information was received from company representative (rep) regarding a patient receiving baclofen (2000 mcg/ml/ 1136.2 mcg/day) via an implantable pump.The indication for use was multiple sclerosis and intractable spasticity.It was reported that the patient was in the intensive care unit (icu) with decreased respirations and overdose.The company representative (rep) was wondering if she needed to report this event.The company representative stated there was no programming errors or alarms logs.Of note, the company representative mentioned that the patient has a history of volume discrepancies.The company representative had a refill last week and unsure if there was any volume discrepancy and the pump respiration volume was not checked at the hospital.The company representative stated there was some mentioned of possible other systemic drug involvement.
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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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Manufacturer Narrative
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H.6.Codes have been updated to reflect the new information.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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(b)(6) 2022 e1 (rep): additional information received from the company representative stated that the weight was asked but unknown.The cause was asked but unknown.An environment/patient factors were asked but unknown.The pump was interrogated but the on-call doctor did not want to make any changes.The resolution of the issue was unknown.There was no issue with the device."this event is no longer a reportable event.Mdr decision updated to not reportable.No additional supplemental mdrs are required unless additional information received makes the event reportable.".
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