MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Device Ingredient or Reagent Problem (2910)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
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Event Date 03/29/2023 |
Event Type
Injury
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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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Event Description
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Information was received from multiple sources (healthcare professional, company representative, consumer) regarding a patient receiving unknown medication via an implantable pump.It was reported a company representative met with the patient for personal therapy manager (ptm) education following a new system implant and a possible pocket infection had been shared with the physician.The incision from the pocket had been swollen, pink/red, and painful.The physician ordered antibiotics for the patient to begin and they were referred to their implanting physician.While seeing the implanting physician a complete drug change, wash and refill took place due to itching from the previous medication.When the physician accessed the catheter access port under fluoro, the fluid obtained had been pink tinged.The physician removed the needle and re-accessed the cap to verify placement of the needle, however the same colored fluid had been obtained.The physician had been concerned with the possibility of infection so the drug had been removed from the pump and replaced with sterile, preservative-free saline.The physician sent the obtained fluid to be analyzed and the patient had been told to continue the previously ordered antibiotics.Patient weight and medical history were asked but remain unknown.At the time of this report it had been unknown if the issue had resolved and the patients status was alive - with injury.
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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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Event Description
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Additional information received from a company representative (rep) reported the culture results had not been available yet, but initial testing of the drainage were "extremely abnormal indicating an infection".
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Search Alerts/Recalls
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