MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Event date: product id: 8731, serial#: (b)(4), implanted: (b)(6) 2006, product type: catheter.Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 03-aug-2007, udi#: (b)(4).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 via a company representative regarding a patient receiving morphine (50 mg/ml at 25 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.It was reported that the pump did not give any pain relief and the patient didn¿t¿ remember if it ever had since the original implant date despite dose increases.There were no reported environmental, external, or patient factors that may have led or contributed to the issue.The catheter was replaced because it was not patent.The pump dose was decreased from 25 mg/day to 2.5 mg/day after the catheter replacement.It was unknown if the issue was resolved.Additional information was received on 22-apr-2022 at which time it was reported that the patient was ¿knocked out¿ right now.Per the reporter, a modified bridge bolus was programmed yesterday to deliver the medication that was left in the internal pump tubing after the catheter replacement and the patient was experiencing underdose symptoms, so they delivered a single bolus today and were planning to program a modified bridge for the remaining volume as the pump medication was being changed to morphine (25 mg/ml at 7 mg/day).
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Manufacturer Narrative
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Continuation of d10: product id 8731; serial# (b)(6); implanted: (b)(6) 2006; product type: catheter.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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