MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Obstruction of Flow (2423); Infusion or Flow Problem (2964)
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Patient Problems
Emotional Changes (1831); Pain (1994); Malaise (2359); Cognitive Changes (2551); Insufficient Information (4580)
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Event Date 08/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8578, lot#/serial#: (b)(4) , implanted: (b)(6) 2021, product type: catheter; product: id 8709sc, lot# /serial# : (b)(4) , implanted: (b)(6) 2008, product type: catheter.Other relevant device(s) are: product id: 8578, serial/lot #: (b)(4) , ubd: 03-dec-2022, udi#: (b)(4) ; product id: 8709sc, serial/lot #: (b)(4) , ubd: 03-dec-2022.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 the consumer via a device manufacturer representative regarding a patient receiving prialt (8 mcg/ml at 3.2752 mcg/day) , morphine (22 mcg/ml at 9.007 mg/day) and baclofen (220 mcg/ml at 90.07 mcg/day) via an implantable infusion pump.It was reported that the patient experienced withdrawal symptoms and went to the emergency room.A dye study was attempted and the catheter was unable to be aspirated.
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Event Description
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Additional information was received from the device manufacturer representative indicated that the patient is contacting a surgeon to discuss replacing catheter.
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Manufacturer Narrative
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Continuation of d10: product id 8578, lot# hg4x2tz09, implanted: (b)(6) 2021, product type catheter.Product id 8709sc, lot# n139701001, implanted: (b)(6) 2008, product type catheter.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 consumer via regulatory body reported the patient had severe withdrawal after the patient's pump was replaced in 2021.It was noted after the surgery the patient became deathly ill.The patient's pump was checked and found to be working.The hcp used ac-arm to see if the catheter had come disconnected and the patient was diagnosed with a blocked catheter.The patient had been scheduled for surgery 3 times but twice the neurosurgeon cancelled.The patient had been in severe pain, it affected their mental health to the point they considered killing themselves.It was noted the patient had never had suicidal thoughts until this complication.The patient noted they had taken prion once for sleep.It was noted a second dye study was ordered that came back with the same results.
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Manufacturer Narrative
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Continuation of d10: product id 8578 , lot# hg4x2tz09, implanted: (b)(6) 2021.Product type catheter.Product id 8709sc, lot# n139701001, implanted: (b)(6) 2008.Product type catheter.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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