MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
No Audible Alarm (1019); Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)
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Patient Problems
Nausea (1970); Vomiting (2144); Malaise (2359)
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Event Date 03/22/2023 |
Event Type
malfunction
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Event Description
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Information was received from a consumer (con) regarding a patient receiving dilaudid (hydromorphone) (unknown dosage/concentration) via an implantable pump.The indication was use for non-malignant pain.The patient reported that the pump was not working.The patient stated in early (b)(6) 2023 when she went to have her pump filled, they typically remove about 2 cc to 3 cc and this time none of the medication was used at all and the whole vial was full.The patient stated the reason for the call was she wanted to make sure a company representative is at her next appointment.The patient then stated since sometime in (b)(6) 2023, the patient was very sick, flat on my back would drink water and could not even keep that down.The patient stated she was sick, throwing up and had nausea.The patient stated she just started feeling better recently.The patient stated her pump was not alarming.The patient stated the doctor did not order a catheter dye study.Troubleshooting was not required.The issue was not resolved as troubleshooting was not needed.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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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.
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Event Description
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Additional information was received from a healthcare provider (hcp) indicated the patient¿s weight was unknown.The cause of the volume discrepancy was not determined.The cause of the patient¿s symptoms was also unknown at this time.It was noted on 2023-may-11 the estimated volume was 7cc vs 20cc actual.Actions/interventions included the patient being scheduled for a dye study.It was noted the patient was not sick at this time and the event was not resolved.
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Manufacturer Narrative
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H6.Correction: device code: a160102 is 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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Manufacturer Narrative
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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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Additional information received from a healthcare provider (hcp).A dye study was performed on (b)(6) 2023.There was no improvement.The cause of the volume discrepancy was asked but unknown at this time.The patient was returned to the surgeon and immune thrombocytopenia (itp) was placed in.The issue was not resolved so they were referred to a spine surgeon.
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Search Alerts/Recalls
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