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Model Number 8578 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 12/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id:8637-20, serial#: (b)(4), implanted: (b)(6) 2021, product type: pump.Other relevant device(s) are: product id: 8637-20, serial/lot #: (b)(4), ubd: 28-aug-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 a healthcare provider (hcp) regarding a patient who was receiving heparin (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that the patient has a catheter that has been dislodged.The hcp confirmed that it was a hepatic pump.The hcp stated that they no longer want to use the therapy and that the patient was bleeding from where the catheter was dislodged.Technical services provided code for the hcp so they can permanently shut off the pump.It was indicated that the pump being turned off due to a problem with the medtronic device/therapy.It was noted that troubleshooting resolved the issue.
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Manufacturer Narrative
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Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.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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Search Alerts/Recalls
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