MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Migration or Expulsion of Device (1395); Material Split, Cut or Torn (4008)
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Patient Problems
Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/20/2023 |
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) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 11-oct-2024, 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 a healthcare professional (hcp) via a company representative (rep) regarding a patient receiving unknown medication via an implantable pump.It was reported the patient has had a reduction in therapy and noticed a bump at the level where the anchor would be located.A ct scan and dye study had been performed and the catheter had been patent but had moved to t5 from t8.The patient had been scheduled an appointment with the surgeon for (b)(6) 2023 to discuss a catheter revision.Surgical intervention was noted to be planned.Patient weight and medical history were asked but remain unknown.At the time of this report the issue had not been resolved and the patients status was alive - no injury.
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Event Description
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Additional information received from the healthcare provider (hcp) via company representative (rep) indicated the patient at pain at the anchor site.It was reported that surgical intervention occurred on (b)(6) 2023.It was reported the silk suture on the anchor had broke and the anchor remained in the fascia however the anchor was flipping on the patient at times which caused discomfort.The catheter tip was placed at t8 during the anchor revision.It was noted that the cause of the catheter migration was unknown.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿.
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Manufacturer Narrative
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Continuation of d10: product id 8780 lot# serial (b)(6) implanted: on (b)(6) 2022 : 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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