MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Device Alarm System (1012); Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Twiddlers Syndrome (4563)
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Event Date 03/15/2023 |
Event Type
malfunction
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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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Information was received from a healthcare professional (hcp) regarding a patient receiving prialt (unknown dose and concentration) via an implantable infusion pump.The indication for use was non-malignant pain.It was reported that the patient's pump flipped (b)(6) and has been moving around ever since.The hcp stated that they can manually move it by hand and that the patient had excruciating pain (b)(6).The patient went in to hcp for a pump refill on (b)(6)2023 and flipped the pump back.The hcp stated that on the same day the patient heard the pump alarm periodically.With a doctor on the line technical services had the hcp pull the logs and it was seen that there were no alerts or issues in the logs.The doctor confirmed that there was no issue with the pump due to the logs and that the pump flipping was the only issue currently going on.Technical services reviewed how a diary could be helpful and that the calling hcp should review the test alarms for the patient.The hcp was going to have the patient monitor with a diary if they hear the alarm happen again.
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Event Description
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Additional information received from a healthcare professional (hcp) reported the patients weight.They stated the cause of the reported alarm was unknown as it had not been alarming during the patients visit.The pump was reported to be flipped back to normal position and the event was resolved.
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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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