MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Device Alarm System (1012); Pumping Stopped (1503); Application Program Problem (2880)
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Patient Problems
Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id 8784, serial# (b)(6).Product type: catheter.Product id 8780.Serial# (b)(6), implanted: (b)(6) 2016, 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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Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen with concentration 2000 mcg/ml at a dose rate of 715.2 mcg/day via an implantable pump.It was reported that a critical pump alarm occurred with a duration of approximately 4 hours, but then went back to normal function.No logs were available when interrogated.It was indicated that the patient stated they experienced increased tone (baclofen) for a short period after the alarming.The physician looked at the logs and no events were recorded. downloading the long report was being considered. it was further reported that the pump was working normally.Regarding factors that may have led or contributed to the issue, it was indicated that there were no reports of electromagnetic interference or magnetic resonance imaging. the physician gave the patient a script for oral baclofen if the device were to alarm again. it was unknown ifthe issue was resolved as of 2023-dec-20. no surgical intervention occurred and no surgical intervention was planned. the pump remained implanted and in-service. the patient was without injury regarding their status as of 2023-dec-20.
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Manufacturer Narrative
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Continuation of d10: product id 8784, lot#/serial# (b)(6), product type catheter.Product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2016, product type catheter.Product id a810, lot#/serial# unknown, product type software; ubd: unknown, udi#: unknown.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 physician had attempted to retrieve logs a number of times.The company representative had requested the physician provide the long report.The long report was however not yet provided.There was no log of a pump stall or what had caused the critical alarm.Regarding if the event including an alarm heard but no issue was recorded in the logs and increased tone were resolved, it was further reported that the pump was functioning normally when the patient later presented to the doctors rooms.The stall and associated alarms had occurred for an approximate three to four hour period.The next pump refill date was to occur before (b)(6) 2024.The estimated pump replacement date was to occur in (b)(6) of 2029.The patient¿s weight at the time of the event was unknown.
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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 a foreign healthcare provider (hcp) via a company representative (rep).It was reported that the rep had interrogated the 2 programmers and neither of them had a log from the date 2023-dec-21.The hcp had reported that there had been no further issues with the patient's pump and no concerns about loss of therapy.
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Search Alerts/Recalls
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