MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191); Data Problem (3196)
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Patient Problems
Muscular Rigidity (1968); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2018 |
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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving baclofen (500 mcg/ml at 30 mcg/day) via an implantable pump for an unknown indication for use.It was reported the hcp had worries about a pump.In the middle of (b)(6) 2018, the pump alerted the patient with a critical alarm.It was not time for filling or battery replacement.It was reported the patient had a low dose of 30 mcg/day, 500 mcg/ml.Upon reading, the pump was in safe state and reset had occurred.Aspiration occurred and there was 16 ml left.It was reported the elective replacement indicator (eri) date was 81 months.The patient called again on (b)(6) 2019 and the pump was alarming again.It was additionally stated the patient was at the hospital.There were no reported symptoms.Further complications were not reported.Additional information was received.A session report was provided.The report indicated the pump was in safe state and pump reset had occurred.The report also showed alert 259 (myptm information invalid) and 262 (error accessing myptm settings), indicating a pump memory error had occurred.It was observed the reservoir volume field displayed "- - - - -" at the beginning of the session.It was confirmed the eri displayed 81 months.It was indicated the pump clock was 1405885 hours and 3 minutes behind the programmer clock and was reset to the programmer clock.The dose was updated to 29.99 mcg/day.The events logs were reviewed.The safe rate in use event occurred on (b)(6) 2019 at 23:12.A reset also occurred at the same timestamp.The pump was updated on (b)(6) 2019 at 14:15 and another safe rate in use event occurred at the same timestamp.Additional information was received.The patient's pump was implanted on (b)(6) 2016.The expected eri date was (b)(6) 2022.It was reported safe state occurred after 2 resets, but logs indicate safe state occurred, then reset, then another safe state.When asked what type of reset occurred, the representative stated, "hard to answer, probable low battery.What happened was that the pump re-setted and the time was out of place so the pump believed it was to old".The patient was not exposed to an mri or any emi prior to the safe state/reset occurring.It was reported when the first reset occurred, it was after an incident when the patient had fallen on the floor.It was stated the cause of the march alarm (safe state/reset) was not determined; it was the same circumstances as the prior reset.The prior pump settings were restored, and during the update the time was adjusted to the correct time.It was stated the issue was resolved when the patient was at a visit, but later that day the issue came back.The patient did not experience any symptoms.Additional information was received.Session logs from (b)(6) 2019 were provided.It was indicated there were no logs to retrieve from (b)(6) 2019.It was stated the patient heard the alarm once an hour.The alarm time for a critical alarm was changed from 1 hour to 10 minutes.It was stated this was bothering the patient very much.A session report from (b)(6) 2019 was provided, indicating the alarm settings were updated.The critical alarm interval was observed to be 10 minutes.
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Manufacturer Narrative
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Product id a810, product type: software.Product id a810, product type: software.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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(b)(4) no longer applies.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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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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Continuation of d10: product id a810 product type software product id a810 product type software product id a810 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 on (b)(6) 2021.It was reported that the pump experienced another pump memory error and reset, which occurred on (b)(6) 2021 the reset caused the data (e.G.Implant date, pump reservoir volume) to be removed and an incorrect eri (elective replacement indicator) date.The software version of the clinician programmer application used to read the pump when these messages appeared was 1.1.342.It was initially reported that the patient's condition was okay with no symptoms as the patient was already on a very low dose, but it was later noted that the patient was a bit more spastic as they did not tolerate oral baclofen.Explant of the pump was planned, but not yet scheduled.It was indicated that the pump would be returned for analysis once explanted.
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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 the foreign hcp via the manufacturer's representative on 2021-feb-19.It was reported that the pump was last programmed prior to the reset on (b)(6) 2020.The pump settings at that time were provided as concentration 500 mcg/ml, dose 30 ,85 mcg/24h.It was also reported that the pump explant date was scheduled for (b)(6) 2021.
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Event Description
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Additional information was received from the foreign healthcare provider (hcp) via the manufacturer's representative (rep) on 2021-mar-02.It was confirmed that the pump was explanted on (b)(6)2021.The hospital was in possession of the pump and intended to return the pump for analysis on 2021-mar-03.The issue was considered resolved at the time of the report.The patient's status at the time of the event was listed as "alive-no injury".It was noted that the pump contained lioresal at the time of the event.
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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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H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Analysis identified a power-on reset had occurred but could not determine the cause.H6: fdm/annex b updated to b01.Fdr/annex c updated to c02.Fdc/annex d updated to d16.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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H6: annex d updated to d15.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.
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Manufacturer Narrative
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H6: annex c updated to c07.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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