MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Dyspnea (1816)
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Event Date 01/09/2023 |
Event Type
Injury
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Event Description
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Information was received from the company representative (rep) regarding the patient receiving (old) dilaudid (hydromorphone) (3.638 mg/day/12 mg/ml) (new) dilaudid (hydromorphone) (3.638 mg/day/10 mg/day) infusion pump.The indication for use was non-malignant pain.It was reported that the patient has issues with breathing and had to intubate her.The technical service confirms that a total prime of 0.352 ml was the correct volume (114.3-18 cm= 96.3 cm x 0.0022 ml/cm = 0.211 + 0.14 ml = 0.352 ml - new pump and catheter.Reviewed the potential that patient had not been getting therapy prior to the pump replacement so therefore the 0.15 mg that had been dispensed in the last hour was too much, but unclear.
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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 received from a manufacture representative reported the cause of the hard time breathing was undetermined.The patient's sats were dropping so the pump was turned to minimal rate.The patient was extubated about 1.5 hours after intubated and did well on nasal cannula.Sats were fine throughout the night.
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