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
Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: catheter.Product id: 8781, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 12-dec-2020, udi#: (b)(4); product id: 8781, serial/lot #: (b)(4), ubd: 31-aug-2022, 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 a consumer regarding a patient receiving baclofen via an implanted pump.The indication for pump use was intractable spasticity.The patient reported that she had surgery on (b)(6) 2021 for something unrelated to the pump.She stated that when the surgeon was doing the surgery, they discovered that the catheter was ¿really messed up¿ and had been prior to surgery.Per the patient, the surgeon took the catheter out but didn¿t do anything else.The patient was wondering how she could get the pump turned off.She stated that she was traveling and was no where near her managing physician.
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Event Description
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Additional information was received from the patient who reported that ¿the surgeon said the wire that anchored the catheter was tangled in scar tissue¿.The cause of the issue was the scar tissue that formed around it.Per the patient, she was due to have the catheter replaced later this summer or fall.
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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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