MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problems
Pain (1994); Therapeutic Response, Decreased (2271)
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Event Date 11/09/2020 |
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) 2016, product type: catheter.Product id: 8780, serial/lot #: (b)(4), ubd: 23-may-2018, 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 professional (hcp) via a company representative regarding a patient receiving dilaudid via an implanted pump.The concentration and dose of the dilaudid at the time of the event was unclear.It was reported that the patient experienced a loss of pain relief.She did not feel like she was getting relief from her pump any longer.There were no environmental, external, or patient factors that may have led or contributed to the issue.The physician tried to aspirate through the side port but was unable to.The patient was taken to surgery on (b)(6) 2020.During the procedure, the physician cut the catheter and isolated the problem to be somewhere within the pump segment, so the old pump segment was removed, and an equal length of pump segment was implanted and attached to the existing spinal segment.The issue was resolved, and it was indicted that the hcp had no further information to provide regarding the event.
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Manufacturer Narrative
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Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2016 explanted: 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.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: 8780, serial# (b)(6), implanted: (b)(6) 2016, product type: catheter.H3: analysis of the catheter identified no significant anomalies.H6:the previously reported evaluation codes no longer apply.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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