MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
Event Type
malfunction
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Event Description
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Information was received from a patient who was receiving intrathecal unknown morphine drug (concentration unknown) at 5.202 mg/day via an implantable pump for non-malignant pain.It was reported that intermittently since their pump refill 'a couple weeks ago,' then confirmed via pump printout and on the patient's calendar (2024-feb-14) they had been hearing a single tone beep that lasts for 'about 3 seconds.' it was reported the patient "sometimes hears it three times - i don't know if it happens when i'm sleeping but if i'm sitting and paying attention - it's at least once per day, but it's happened twice today." it was also reported "it's (the alarm) is everywhere i am - at work, the car, my home, my bathroom, or while in a meeting." the patient had been working with the healthcare provider (hcp) but nothing showed up on the pump logs.The patient did not have a personal therapy manager (ptm) but did have a pump printout.The pump printout from (b)(6) 2024 showed: "refill pump before (b)(6) 2024, beginning of session: 1.7ml, low reservoir alarm volume: 2.0ml, current settings: monday - sunday simple continuous - step 1: 12am - 12am - 24hrs, morphine 5.202mg is 24 hour dose." the patient confirmed that the hcp filled the pump to 20ml at the refill.The patient was redirected to the hcp.
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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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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 was received from the healthcare provider (hcp) indicated that the patient's weight was 175 lbs and the issue had resolved.No additional information provided.
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