MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Granuloma (1876); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/06/2022 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider regarding patient receiving morphine drug via an implantable pump.The indication for use was non-malignant and chronic low back pain.The healthcare provider reported the patient came into the hospital with withdrawal symptoms.The healthcare provider believed they had a clinician programmer to check the pump.Additional information was received on (b)(6) 2022 from the managing healthcare provider who reported "over the weekend" the patient went to er (emergency room) with withdrawal symptoms and the er doctor was concerned the pump was not functioning.The reporter was asking for a representative to check the pump.
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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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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 received reported they were not sure what the issue was in regards to the er doctor was concerned the pump was not functioning.The company representative interrogated the pump and it appeared to be ¿working ok¿.The cause for the patient¿s withdrawal symptoms were not determined.Per the reporter, no one knows why the patient was having pain, they never did a dye study as this had to be an outpatient procedure.The patient would be set up with the pain clinic to have a catheter dye study to see if there is anything wrong with the catheter.The patient¿s weight was noted to be greater than 200lbs.The status of the devices were noted as undetermined at this time.
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Manufacturer Narrative
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Continuation of d10: product id 8780 serial# (b)(6) implanted: (b)(6) 2018: product type catheter other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), ubd: 2019-12-12, udi#: (b)(4) h6.Device code: a24 applies to the 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 a healthcare provider (hcp) indicated the patient was having issues with his pump/therapy and they wanted to confirm there was nothing going on with the catheter.The patient had experienced symptoms of withdrawal and increased pain.They have the patient on oral opiates and clonidine to manage his withdrawal.It was noted they switched his opiates around a little bit, and at times, the patient felt his pump was working.He would get relief and he would only take medications if he needed it.It was reported the pump telemetry looked okay, no motor stalls or "anything like that".At the (b)(6) 2022 pump refill they had an expected residual volume (erv) 3.1 ml and actual residual volume (arv) 4 ml.The hcp would like to do a dye study and inquired about having a company representative (rep) present for that.They would like to rule out a possible granuloma.Current drug information included: morphine 20 mg/ml at 2.9 mg/day.
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Search Alerts/Recalls
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