MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Skin Discoloration (2074); Post Operative Wound Infection (2446); Swelling/ Edema (4577); Insufficient Information (4580)
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Event Date 04/24/2017 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted pump system.The pump was used to deliver prialt (ziconotide) 25mcg/ml at an unknown dose.It was reported that an infection at the catheter site occurred post-operatively.The patient experienced visual signs of infection.There was no allegation related to the pump therapy.A pump and partial catheter removal occurred on (b)(6) 2023.The pump was at end of service (eos).There was no allegation related to the pump.A small portion of the catheter was tied off and left abandoned.A replacement would occur in the future.The patient planned to follow up with wound care and an infectious disease doctor before having a new pump and catheter implanted.It was asked but unknown if any environmental, external, or patient factors that may have led or contributed to the issue.There were no diagnostics/troubleshooting performed.At the time of this report, the issue was not resolved and the patient status was "alive-no injury".The patient's weight and medical history was asked but was unknown.
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Manufacturer Narrative
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Concomitant products: product id 8709, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2023, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4) , 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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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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Continuation of d10: product id 8709 serial# (b)(6) implanted: (b)(6) 2017 explanted: (b)(6) 2023 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 received from the company representative reported that in regards to the visual signs of infection, the patient exhibited redness, discoloration, and swelling at the time of the event.The healthcare provider deemed it safer to leave the catheter abandoned versus trying to remove it.A system replacement had not been scheduled yet.
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Search Alerts/Recalls
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