MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
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Patient Problems
Pain (1994); Twiddlers Syndrome (4563)
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Event Date 02/09/2023 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving dilaudid (500 mcg/ml at 50 mcg/day) via an implanted pump.It was reported that the patient¿s pump had flipped, and the patient complained of a lack of pain relief as a result.With regards to any environmental, external, or patient factors that may have led or contributed to the issue, it was noted that the hcp believed the patient had been manually flipping the pump repeatedly.The hcp attempted to aspirate through the side port but was unable to.He decided to revise the patient¿s pump pocket and found that the pump had probably been flipped dozens of times by the patient.The catheter was kinked and there was significant memory as the catheter was continui ng to kink, so he decided to cut out the affected catheter and added a new pump segment to the existing/original spinal segment.He was then able to successfully aspirate through the side port.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
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Manufacturer Narrative
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Continuation of concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2023, explanted: (b)(6) 2023 and product type: catheter.Suspect medical device information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 08-dec-2024 and 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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Manufacturer Narrative
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The catheter was returned and analysis identified twisting and a kink in the catheter body.Analysis identified the collet was missing from the catheter to catheter connector.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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