MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Insufficient Flow or Under Infusion (2182); Human-Device Interface Problem (2949)
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Patient Problems
Fatigue (1849); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/01/2022 |
Event Type
Injury
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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 consumer (con) who was receiving hydromorphone, at unknown concentration and dose via an implantable pump for non-malignant pain.It was reported that the patient inquired about dosing protocol for a pump after it had been empty.The patient clarified sometime in december their pump started alarming due to empty reservoir and for 'a few days' couldn't find where the beeping was coming from.The patient stated it beeped 'once in a while' and then 'then it beeped 5 times every 10 min.The patient stated on (b)(6) 2022 they had problems staying awake and their friends realized it but the patient did not.The patient withdrawal from it and didn't realize it.The patient was in an accident as a result of this.They saw a yellow light and next thing they knew they had hit the truck.The patient stated "they kind of passed out".While on the call the patient stated their primary care doctor said that this could have killed them if it happened rapidly.The accident was so bad the patient could have died.When patient services attempted to clarify the events and event date the patient stated they were having more and more pain and their friends sa id the patient closed their eyes on the same day of the accident.The patient friends told them they should not have let them drive.The patient stated their refilled on 2023-jan-04 and the physician upped it a little the next week but said they had to go down to 0 or basically 0.On 2023-feb-6 they were only getting 0.6 of the medication when it was at 4mg or mcg before and they were getting no oral medication.The patient stated it had gotten bad and had developed problems because of this.The patient mentioned the pain was so severe that they wanted to operate.Patient services attempted to clarify and the patient stated 'no, not the pump.I like the pump.Patient services reviewed, medtronic was not medically trained and redirected to healthcare provider.The patient provided product feedback that the pump alarm was difficult to hear when it was coming from their stomach and should be louder volume or different type of beep because everything else beeps.
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