MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
Injury
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Event Description
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Information was received from a patient and a healthcare provider via a manufacturer representative regarding a patient receiving unknown baclofen via an implantable pump.The indications for use were unknown.It was reported that the patient came in on (b)(6) 2023 to have a catheter revision because the pump continued to flip.The healthcare provider (hcp) confirmed that this patient was a "constant flipper" and their abdomen tissue was "very loose." the patient stated that they went in for their refill on (b)(6) 2023, and they could not interrogate the pump.They then palpated and realized the pump was once again flipped.They did not change the patient's pump dosing and instead started them on oral baclofen.The patient stated they were on "a lot of oral baclofen" but did not specify how much and this was not disclosed for patient privacy reasons.The hcp scheduled the patient for a catheter revision and opted to have their pump moved from their abdomen to their buttock region.The rep met with the patient and was able to read their pump, and they said they "recently had it flipped back." the hcp opened up the abdominal pocket and it was clear the pump had been flipping because the pump segment of the catheter was coiled a few times.The hcp then went to the patient's backside and started working on the pump pocket that would be in the buttock region.They then cut the pump segment of the catheter and free flowing cerebrospinal fluid (csf) was observed.The hcp then tunneled the new pump segment to the new pump pocket where they placed the existing pump.They aspirated from the cap and had free flowing csf.The hcp did not make dosing changes and expressed that they can decrease the oral baclofen and start utilizing the pump therapy with this dose that was working for the patient before their pump flipped.The patient was currently 170 pounds and had "recently lost 40 pounds" which may have contributed to the pump flipping.
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name ascenda; product id: 8780 (serial: (b)(6); product type: 0184-catheter; implant date: on (b)(6) 2021; udi: (b)(4); brand name: ascenda; product id: 8784 (serial: (b)(6); product type: 0184-catheter; implant date: on (b)(6) 2022; explant date: on (b)(6) 2023; 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.
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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 was received from a healthcare provider (hcp) via a company representative (rep) who reported that the event resolved.
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Manufacturer Narrative
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Continuation of d10: product id 8784, serial# (b)(6), product type: catheter.Product id 8780 serial# (b)(6), implanted: (b)(6) 2021, product type: catheter.Product id 8784, serial# (b)(6), implanted: (b)(6) 2022, explanted: (b)(6) 2023, product type: catheter.Product id 8784, serial# (b)(6), product type: catheter.H3.Analysis of the catheter pump segment (b)(6) identified twisting in the catheter.Visual inspection identified there was damage to the transition tubing.Analysis identified a kink in the catheter body.Analysis of the catheter pump segment (b)(6) identified a kink in the catheter body.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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