MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Obstruction of Flow (2423); Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving clonidine (unknown dose and concentration), compounded baclofen (unknown dose and concentration), dilaudid (hydromorphone) (unknown dose and concentration), and bupivacaine (unknown dose and concentration) via an implantable pump for unknown indications for use.It was reported on (b)(6) 2021 the patient presented to the operating room for a pump replacement secondary to normal end of battery life and an occlusion at the proximal segment of the catheter was observed.The implanting physician was unable to insert the spinal segment in the desired space.The pump segment was coiled in the pump pocket and the pump was programmed to minimal rate.The plan was to refer to a neurosurgeon.On (b)(6) 2021 the existing catheter was removed, and a new catheter was attempted to be implanted but the spinal segment could not be threaded up to the desired level.Therapy was suspended and the pump was programmed to minimal rate.The outcome was noted as ongoing.The device diagnosis was catheter occlusion.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was (b)(6) 2021.
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Manufacturer Narrative
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Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 20-nov-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Continuation of d10: product id 8781 lot# serial# (b)(6) implanted: (b)(6) 2015 explanted: (b)(6) 2021 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 healthcare provider via a clinical study reported that the patient was receiving dilaudid (3 mg at 1.01504 mg/day), bupivacaine (30 mg at 10.1504 mg/day), compounded baclofen (400 mcg at 135.22868 mcg/day) and clonidine (250 mcg at 84.58667 mcg/day) via an implantable pump.
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Event Description
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Additional information was received from a healthcare provider via a clinical study indicated that the surgery was being postponed due to an accident.The patient was being treated with oral morphine.
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Manufacturer Narrative
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Continuation of d10: product id: 8781, serial#: (b)(6), implanted: 2015 (b)(6), explanted: 2021 (b)(6), 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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