MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
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Patient Problem
Tachycardia (2095)
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Event Date 01/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 17-oct-2010, udi#: (b)(4).The manufacturer¿s device registration system indicates that the pump segment of the catheter was revised.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) via a company representative regarding a patient receiving lioresal (2000 mcg/ml at 1592.0 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.It was reported that the patient had a routine pump replacement procedure and then ended up back in the hospital with tachycardia and signs of withdrawal.The patient was evaluated by neurology and neurosurgery.When they aspirated the pump, they found all 40 cc remaining in the pump when they were expecting 37 cc.A catheter dye study was done, and they were able to aspirate 0.4 cc, but when trying to push dye there was resistance and pressure and the dye study could not be completed.A catheter revision procedure was being scheduled.It was unknown what caused or contributed to the issue.
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Manufacturer Narrative
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Continuation of d10: product id 8709sc lot# serial# (b)(6) implanted: (b)(6) 2009 explanted: (b)(6) 2022 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 was received from a healthcare provider (hcp) via a company representative (rep) indicated during the catheter revision on (b)(6) 2022, the catheter was found to not aspirate well.The cause was not determined, but it was found to be an issue with a portion of the catheter between the abdomen and anchor site.A new pump segment was added to a portion of the original 8709 and connected at the spinal incision.The physician discarded the catheter.
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