MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Muscular Rigidity (1968); Tingling (2171); Therapeutic Response, Decreased (2271); Numbness (2415)
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Event Date 05/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 21-mar-2020, udi#: (b)(4).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 company representative (rep) regarding a patient receiving intrathecal lioresal 2000 mcg/ml at 1200 mcg/day via an implanted pump.It was reported the patient had some numbness to the left lower limb and had an mri over the weekend with negative results.The pump logs were showing no alarms.It was noted the pump serial number was included in the fb field communications.It was also reported the patient had increased spasticity since this weekend and the patient was seen in the emergency room (er).On the date of this report, the patient saw the healthcare provider (hcp) and they gave the patient a therapeutic bolus with no results.The rep was on her way to the clinic to assist with a catheter access port (cap) aspiration and possible cap dye study.Additional information was received on 28-may-2020 that reported the dye study was done and the physician thought it was the catheter was the issue but was told the pump was one of the recall pumps, so everything was replaced tuesday (b)(6) 2020.After the replacement the physician ordered a new dose/cut the dose in half to 550ug/day.The patient was doing ok on that dose as of yesterday.No further complications were reported or anticipated.
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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: analysis results were not available at the time of this report.A follow-up report will be sent once analysis is complete.H6: the device code and the evaluation codes have been updated for this event.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 healthcare provider (hcp) via the manufacturing representative (rep).It was reported the patient had experienced loss of efficacy and withdrawal like symptoms.It was also noted the patient experienced numbness and tingling down one leg.The patient had recovered without sequela following the system replacement on (b)(6) 2020.It was noted a dye study had been performed and the healthcare provider could not see a leak in the catheter.The dye study showed nothing.However, the hcp still felt something was wrong with the catheter.The pump was replaced due to fear of the device being part of the recall.The pump and catheter were returned to the manufacturer for analysis.
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Manufacturer Narrative
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H3: the returned devicse passed all testing in the laboratory and no anomalies were identified.Continuation of d11: product id 8780 serial# (b)(6) implanted: (b)(6) 2018 explanted: (b)(6) 2020 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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Additional information was received from an hcp via a manufacturer representative on (b)(6) 2020.It was reported that there were no known external events that could contribute to the event.The patient's symptoms had resolved.
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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.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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Search Alerts/Recalls
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