MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Filling Problem (1233); Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: tm90t0, serial# (b)(4), product type: accessory.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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Information was received from a consumer (con) regarding a patient receiving unknown medication for non-malignant pain via an implantable pump.It was reported the patients handset and communicator would not hold a charge.Patient services attempted to clarify report of the communicator not holding a charge.It was unclear if the communicator would not hold a charge, or if the patient believed the communicator would not hold a charge because the battery indicator light would turn red when plugged in.Regarding the event date, the patient reported "ever since i had this one, it's been hard to find exactly where the pump is.The pump flipped a couple times.I've had it 11 years, and they've had hard time to refill it, and have been having to do a few pump adjustments.So it's hard to find exact place on pump with this communicator" {refer to manufacturing report # 3004209178-2020-07293 regarding the patient's previous pump that had flipped and had difficulty refilling}.General use was reviewed with the patient and it was recommended the patient continue to monitor.The patient reported the issue had seemed to gotten worse over the past 6 to 9 months.
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Search Alerts/Recalls
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