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 Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2016 product type catheter product id 8784 lot# serial# (b)(4) implanted: (b)(6) 2022 product type catheter.Product id 8637-20 lot# serial# (b)(4) product type pump.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 11-jul-2018, udi#: (b)(4); product id: 8784, serial/lot #: (b)(4), ubd: 02-dec-2022, 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 (rep), healthcare provider (hcp)) regarding a patient who was receiving unknown morphine drug (3000 mcg/ml at 1920 mcg/day) via an implantable pump for non-malignant pain.It was reported that during a routine pump replacement on (b)(6) 2022, it was found that there was likely a catheter kink due to the patient's pump flipping.They were able to identify the pump segment was kinked and replaced it with a portion of the 8784 catheter.From there they could not aspirate from the cap (catheter access port) even with the new pump.It was determined to close and revise the entire catheter at a later date.
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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).It was reported that they attempted aspiration from cap port, cleared cap with suction and it was still unsuccessful.Attempted aspiration directly from the catheter with a 3 cc syringe, removed and replaced visibly kinked pump segment and the aspiration still remained unsuccessful.It was unknown when the catheter revision surgery date was scheduled for.The hospital discarded the devices.The patient's weight was asked, but unknown.
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