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); Insufficient Information (3190)
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Patient Problems
Pain (1994); Shaking/Tremors (2515); Ambulation Difficulties (2544); Insufficient Information (4580)
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Event Date 07/22/2022 |
Event Type
malfunction
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Event Description
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Information was received from a patient who was receiving bupivacaine and morphine via an implantable pump for non-malignant pain.It was reported that the pump likely began non-critical alarming about a week ago then about 3 days ago the critical alarm began.It was stated that they had not known what the sound was and thought it was related to the thunderstorm they recently had, something around their home, or their alarm system.It was noted that they believed the pump alarm was setting off their security alarm system at home.Additional information received from the consumer (con) reported that their pump has been out of medication since (b)(6) 2022 and has "been in a lot of pain".The patient stated that they had an appointment with their healthcare provider who did not have any medication for their pump.The patient stated that the healthcare provider gave the patient other medication that did not do anything for the patient.The patient reported that several times they were shaking, soaking wet, cannot get up and move around, cannot walk the dog, cannot eat or drink anything hot, and "i look like a drug addict".The patient also mentioned that they were told that their healthcare provider was going to decrease the pump medication by 25%.The patient mentioned that they cannot hear alarm because they are in their 70's.
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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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