MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Obstruction of Flow (2423); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
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Patient Problems
Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2021 |
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) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 19-aug-2021, 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 healthcare provider via a company representative regarding a patient receiving morphine via an implantable pump.A catheter occlusion and drug volume discrepancy were reported.The environmental, external or patient factors that may have led or contributed to the issue was the patient falls a lot.The diagnostics and troubleshooting performed was a catheter dye study, they were unable to aspirate the catheter.The actions and interventions taken to resolve the issue was a catheter revision would be scheduled.Surgical intervention did not occur, was planned but had not been scheduled.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.
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Manufacturer Narrative
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Continuation of d10: product id: 8780; serial# (b)(6); implanted: (b)(6) 2019; explanted: (b)(6) 2021; 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 a healthcare provider (hcp) via a company representative who reported that the patient had surgery for the occluded catheter and there was found to be scar tissue in the pump pocket that likely caused the occlusion.The physician dissected the catheter from the scar tissue; trimmed several centimeters of the old catheter; and then added a new pump segment to connect to the pump after which the catheter was able to be easily aspirated.The physician tried to identify the occluded piece of the removed catheter by injecting saline through it with a 25-gauge needle and it appeared the occlusion was at the connector pin piece.
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Manufacturer Narrative
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H3: analysis of the catheter revealed a user related hole in the catheter body in addition to damage to the transition tubing.H6: the results code 114 and conclusion code 19 pertain to the analysis finding of a user related hole in the catheter body.The results code 180 and conclusion code 4315 pertain to the analysis finding of damage to the transition tube.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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