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 Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_cath lot#: serial#:, implanted:, explanted:, product type: catheter.Other relevant device(s) are.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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Event Description
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Information was received from a manufacturer representative regarding a patient who was receiving an unknown drug vian an implantable pump for an unknown indication for use.It was reported that the manufacturer representative was contacted by a healthcare provider (hcp) regarding an issue at pump refill.They decided to aspirate the catheter and pulled back about 2 ml but what they aspirated was a "weirder yellow" and "something they had not seen or experienced before." no patient symptoms or complications were reported.
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Event Description
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Additional information was received from a healthcare provider (hcp) via a company representative who reported that the cause of the discolored fluid was not determined.With regards to any diagnostics/troubleshooting performed related to the event, ¿n/a¿ was noted, and it was noted that no actions were taken to resolve it as there was nothing to resolve.
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Manufacturer Narrative
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Continuation of d10: product id 8709sc lot# serial# (b)(6) implanted: (b)(6) 2007, product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8709sc serial/lot# (b)(6), ubd 2009-11-10, udi# (b)(4).G8 ¿ the correct manufacturing site id for the manufacturing report number is p1277 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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