MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphasia (2195); Cognitive Changes (2551)
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Event Date 04/19/2022 |
Event Type
Injury
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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.
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Event Description
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Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving dilaudid (hydromorphone) (unknown concentration or dose) and bupivacaine (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that the patient's husband reported that the patient was inpatient (at a hospital cpsc providers do not have privileges) for severe altered mental status.They reported that a medtronic representative decreased the pump in the hospital on (b)(6) 2022.The patient's husband reported the patient "did wake up from her stupor" on (b)(6) 2022, one day following the decrease; however, reported that the patient continued having difficulty communicating.On (b)(6) 2022, the patient presented for pump refill and had fully recovered.Per provider, the source of the severe altered mental status was not definitive, but it did improve following it rate decrease.Device diagnosis was not applicable.It was indicated that the relationship of the event to the device/therapy and drug was possibly related.Drug action that caused event was and increase in hydromorphone dose.The event was resolved without sequelae.
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Search Alerts/Recalls
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