MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of concomitant medical products: product id a810 ,serial# unknown , product type :software.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 healthcare provider (hcp) via a company representative regarding a patient receiving fentanyl (4000 mcg/ml at 8000 mcg/day) via an implanted pump.The indication for pump use was spinal pain.It was reported that the patient¿s pump went empty on (b)(6) 2022, so on (b)(6) 2022 at 3:14 pm the hcp filled the pump with saline and updated the pump.The hcp kept the programming as fentanyl with the same concentration of 4000 mcg/ml and changed the dose from 8000 mcg/day to 200 mcg/day.The patient experienced withdrawal symptoms and had to be admitted to the icu (intensive care unit) on (b)(6) 2022 due to the change in programming.Today they brought the patient back in to the managing hcp¿s office after 24 hours with saline running in the system and they were going to be filling the pump with new medication (morphine 30 mg/ml at 3 mg/day) and were requesting assistance with programming an advanced bridge bolus.
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Event Description
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Additional information received from a company representative (rep) reported that the patient's weight was asked but unknown.The ap plication software version was asked but unknown.
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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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