|
Model Number NEU_UNKNOWN_PUMP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Concomitant medical products: product id: 8780, serial# (b)(4), implanted (partial): (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 02-jan-2021, udi # (b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a healthcare provider via a company representative regarding a patient who was to receive an unspecified drug of unspecified concentration at an unspecified dose rate via an implantable pump for an unknown indication for use.It was reported that during an implant procedure, the patient¿s heart rate declined and blood pressure dropped so the anesthesia aborted the case.The patient was having a pump implant and the catheter was anchored and ready to tunnel when the patient¿s heart rate dropped.The type of drug in the pump was indicated as having been none.The patient had a partial catheter implanted in the spine.Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient had no cardiac history.No diagnostic testing or troubleshooting was performed.Actions taken to resolve the issue was indicated as having been none and the patient was admitted to the hospital.It was unknown if the issue was resolved at the time of the report.The patient was with alive with injury regarding their status at the time of the report.The patient¿s medical history was indicated as having been requested but was unknown.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
The previously selected hospitalization on the initial report is no longer applicable.The type of report was changed from previously being a reportable serious injury to now a reportable malfunction regarding additional information received.The patient codes (b)(6) were replaced with (b)(6).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.
|
|
Event Description
|
Additional information was received via a healthcare provider.The patient¿s date of birth was clarified.It was indicated that no pump was implanted when the event occurred.The patient developed an acute coronary syndrome with ekg changes and arrythmia after 1 ml of bupivacaine was infused for spinal anesthesia.Regarding the circumstances that led to the heart rate having declined, blood pressure having dropped, and patient having been hospitalized, a spinal block was indicated.The patient was given pressors and resuscitation measures which were started immediately.The catheter was anchored and tied off and the pump was never implanted.
|
|
Search Alerts/Recalls
|
|
|