MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Erythema (1840); Fall (1848); Loss of consciousness (2418); Unspecified Tissue Injury (4559); Insufficient Information (4580)
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Event Date 06/28/2022 |
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 healthcare provider (hcp) and consumer via a company representative regarding a patient receiving bupivacaine (7.5 mg/ml at 1.5 mg/day) and morphine (40 mg/ml at 8 mg/day) via an implanted pump.The indication for pump use was failed back surgery syndrome and non-malignant pain.It was reported that within the past few weeks, the patient reported that ¿it felt like her pump exploded and she felt this rush throughout her body (in her lungs and back) and she passed out on the kitchen counter/bar area and fell off and woke up on the floor.Per the reporter, the hcp had just done a refill, and they were expecting 3.5 ml and got back 4.5 ml.There was no evidence of any alarms or problems with the pump.The hcp did visualize the pump with an ultrasound, and everything appeared to be intact.The patient showed the reporter a picture and it looked like she had some scratches, and it was red around the pump.
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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 a healthcare provider (hcp) via the company representative who reported that the cause of the event was not determined.The hcp decided to just watch it and have the patient let him know if it happened again.
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Search Alerts/Recalls
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