MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017); Failure to Disconnect (2541); Infusion or Flow Problem (2964)
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Patient Problems
Sleep Dysfunction (2517); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2022 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted pump system.The pump was used to deliver fentanyl 500mcg/ml at 130mcg/day and bupivacaine 8mg/ml at an unknown dose.It was reported that the patient had recently lost weight and wanted to decrease the pump size to a 20ml reservoir.The pump was "just sticking out a lot".The patient had pancreatitis and just had extreme weight loss.There were no symptoms of withdrawal or other issues.During the pump replacement on (b)(6) 2022, when the doctor attempted to aspirate the catheter, there was determined to be no flow.The doctor attempted to aspirate the catheter through the pump and through the catheter only with no success.The patient had shown no signs of withdrawal, so the doctor decided to prime the catheter, despite being warned that they would push approximately 100mcg of fentanyl over 21 minutes.The priming bolus performed incorrectly and the warning screen was ignored.The doctor determined that, since the patient had no signs or symptoms of withdrawal, that they would bolus the pump tubing and catheter in the operating room where the patient could be monitored and intubated if needed.The patient slept for a few hours after the bolus, but was otherwise fine.The doctor also replaced the pump segment of the catheter in the pocket because they were unable to disconnect the sutureless pump connector from the pump.The doctor replaced the pump connector segment and connected it to the new pump.It was unknown if any environmental external, or patient factors that may have led or contributed to the issue.The cause of the inability to aspirate from the cap and no csf flow from the catheter was not determined.At the time of this report, the issue was resolved and the patient status was "alive-no injury".The patient's weight was asked but would not be made available.The patient's past medical history included pancreatitis.
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Manufacturer Narrative
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Concomitant medical products: product id 8781 lot# serial# (b)(4) implanted: (b)(6) 2018 product type catheter product id ne u_unknown_prog lot# serial# unknown product type programmer, physician.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 03-may-2019, udi#: (b)(4); product id: neu_unknown_prog, serial/lot #: unknown, ubd: 03-may-2019, 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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