MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Fluid/Blood Leak (1250); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
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Patient Problems
Muscle Weakness (1967); Dizziness (2194); Insufficient Information (4580)
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Event Date 04/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2022, product type catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 03-dec-2012, udi#: (b)(4).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) regarding a patient who was receiving unknown drug via an implantable pump for non-malignant pain, post lumbar laminectomy syndrome, lumbar radiculopathy, and spinal pain indications.It was reported that the patient had a fall ¿sometime in (b)(6)¿ and came in for their pump refill on (b)(6) 2022 reporting that they had been feeling dizzy, weakness, and unable to feel their boluses since this fall.They did the refill and did not have any volume discrepancies.A dye study was done on (b)(6) 2022 where the physician could not aspirate the catheter.They decreased the patient's dose on (b)(6) 2022 from 8 mg/ml of morphine with 1 mg boluses 6 times per day to 4 mg/ml a day without boluses.The physician brought the patient to the operation room and opened up the spinal incision.They disconnected the spinal segment from the pump segment and put a needle in the spinal segment and aspirated sluggishly about 1 cc.It had a lot of catheter memory and was dynamically kinking.From there the physician did a bolus from the pump while it was disconnected to see if the pump side of the catheter would drip with the bolus.They saw drug dripping at the connector pin and decided to replace the spinal segment entirely.An 8598a was opened and the catheter was replaced.It was flowing csf (cerebrospinal fluid) and the physician was able to successfully aspirate.The issue was resolved at the time of report.The patient's status at the time of report was alive - no injury.
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Manufacturer Narrative
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H3: analysis of the catheter revealed catheter body; dark residue occlusion in dispensing holes-event related; anchor broken.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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H10: corrected information: the following should have been included in follow up number 001: the pump was used to deliver morphine17.6mg/ml at 3.997mg/day, fentanyl 2000mg/ml at 454.1mg/day and bupivacaine 25mg/ml at 5.859mg/day.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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