MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pocket Erosion (2013); Scar Tissue (2060)
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Event Date 03/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 30-sep-2021, udi#: (b)(4).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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving an unknown drug via an implantable pump for unknown indications for use.It was reported that the patient had a red scar over the pump site, irritation, and the pump was protruding through the skin.The irritation was first noticed a few weeks ago but the patient denied any trauma to the area.The pump was explanted on (b)(6) 2021 due to risk of infection.The issue was resolved.The patient's injury had not healed yet but they were stable post-surgery.The patient's weight and medical history were asked but unknown.
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Event Description
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Additional information was received from the rep who reported that the devices were discarded.
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Manufacturer Narrative
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Continuation of d10: product id: 8780, lot#serial#: (b)(6), implanted: on (b)(6) 2019, product type: catheter, product id: 8780, lot#serial#: (b)(6), implanted: on (b)(6) 2019, 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.
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