MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
Pain (1994)
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Event Date 03/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 (manufacturer representative, healthcare provider) regarding a patient who was receiving bupivacaine (5000 mcg/ml at min rate mcg/day), clonidine (150 mcg/ml at min rate mcg/day), and morphine (5000 mcg/ml at min rate mcg/day) via an implantable pump for unknown indications for use.It was reported that the pump logs showed that the pump reset due to firmware error (code 2c); there was also the error codes 07 and 01 seen in the logs which are indicative that the pump reset and was in minimum rate mode.The logs revealed these events occurred on (b)(6) 2022 at 1256am and the patient was not in any odd environments.It was noted that the patient was hearing an active alarm was feeling increased pain and started to feel some withdrawal type symptoms.They were able to program it out but the pump was still audibly alarming.It was reviewed how to silence the active alarm.The patient was going to stay at office to make sure they didn't hear the alarm.
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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 was received from a healthcare provider (hcp) via a company representative who reported that the cause of the pump reset was not determined.
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