MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Retraction Problem (1536); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 8780 lot# serial# (b)(4) product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 25-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 provider (hcp) via company representative (rep) regarding a patient receiving morphine (1 mg/ml, 0.1 mg/day) via implanted infusion pump.It was reported the while trying to implant the catheter, the stylet pushed through the proximal tip of the catheter.That catheter was replaced with a new catheter.There were noenvironmental, external, or patient factors that led or contributed to the issue.There were no diagnostics/troubleshooting performed.The issue was resolved at time of event.The patient's status at time of report was alive - no injury.The patient's weight and medical history were asked, but unknown.No symptoms were reported.Additional information received from the healthcare provider (hcp) via company representative (rep) reported that the cause of the stylet pushing through the proximal tip of the catheter was not determined.The rep indicated that the catheter was damaged.
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Search Alerts/Recalls
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