MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Data Problem (3196)
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Patient Problem
Muscular Rigidity (1968)
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Event Date 12/14/2023 |
Event Type
malfunction
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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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It was reported that the hcp reported seeing codes 112 and 243 when reading the pump.The rep mentioned the hcp was reading the pump as the patient was more stiff and wanted to know if that might be related.Technical services reviewed checking logs to differentiate between a pump-detected versus programmer-detected error and then attempting to update.The call was disconnected therefore no additional information was known regarding the event.It was unknown if the issue was resolved at the time of this report.
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Manufacturer Narrative
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Concomitant medical products: product id a810 version: 1.1413 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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Event Description
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Additional information was received from a foreign healthcare provider via a company representative.The date of pump implant was unknown.The patient was coming in for a dose adjustment and they had a memory error when connecting to the pump.The clinician programmer software version being used at the time of the event was 1.1413.Regarding if the pump memory error was determined to be pump detected or programmer detected, it was indicated that from the company representative¿s conversation with technical services, it was programmer error since it appeared in the pump¿s log.It was noted as having been confirmed with technical support if any other actions were necessary other than verifying the log and follow patient¿s next visit to assure no other alarm.The clinicians had to reprogram the pump for it to restart, so it seemed like a memory problem of the parameters.It was fine after this communication.The cause of the pump memory error was indicated as unknown.The issue was resolved.As per the pump¿s log, the pump administered baclofen with concentration 1,000.0 mcg/ml at a dose rate of 569.7 mcg/day and clonidine with concentration 750 mcg/ml at a dose rate of 427.25 mcg/day.
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