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Model Number 8637-20 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)
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Event Date 05/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician.Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown.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 consumer regarding a patient who was receiving morphine of an unknown concentration at an unknown dose rate via an implantable pump for non-malignant pain and chronic low back pain.It was reported that the patient had second thoughts on getting another pump.When he went in to get a refill, they stated the battery was dead and there was still a lot of morphine left in the pump.The patient was not in pain at that time.They took out the morphine and the patient left tuesday after the appointment.That night and wednesday, the patient had pain like he never had in his life.It was further noted that they put morphine back into pump and used two different gauges, and they wondered if it was even working.They gave the patient oxy and valium and the patient wondered if there was something he could take for the pain.The patient could not get surgery for a month and he was on a list for this.It was further reported that they determined the pump was dead and the patient was at 7 years as of (b)(6) 2020.Up until that day the patient was not in pain, so the patient stated the pump must have been working.The patient could not sleep and was just moaning.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product id: neu_unknown_prog, serial# unknown, product type: programmer, physician.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 was received from the healthcare provider (hcp) via a device manufacturer representative regarding a patient indicated that the pump had reached end of service and the patient experienced withdrawal symptoms.It was noted that the patient was non-compliant had not scheduled a replacement surgery.Surgery was planned for (b)(6) 2020.The issue was currently unresolved and the patient was alive with no injury.No further complications have been reported as a result of this event.
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Manufacturer Narrative
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Concomitant medical product: product id neu_unknown_prog lot# serial# unknown implanted: explanted: product type programmer, physician 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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On 2020-june-02, additional information was received from the manufacturer representative (rep).On (b)(6) 2020, the patient had the pump replaced with a new pump and prophylactic replacement of the catheter.There was no complaint associated with the catheter.The explanted devices were sent to pathology per protocol.The customer did not want them returned.Morphine 10 mg/ml, daily dose; 1 mg with a ptm of 0.1 mg 3x/24 hour.
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Manufacturer Narrative
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H6: fdd codes a2303 and a1407 removed as they are not applicable to this 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.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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Search Alerts/Recalls
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