MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-40 |
Device Problem
Pumping Stopped (1503)
|
Patient Problems
High Blood Pressure/ Hypertension (1908); Pain (1994); Vomiting (2144); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/13/2023 |
Event Type
Injury
|
Event Description
|
Information was received from a consumer regarding a patient receiving fentanyl via an implantable pump.The indication for use was spinal pain.The patient¿s friend/family member reported that the patient¿s pump started doing the critical alarm today and the 8835 (personal therapy manager) was showing code 8476 (motor stall).The reporter stated that they called the healthcare provider but the office is closed today.The patient had not had a recent mri and the pump was not due to be refilled until (b)(6) 2023.The patient was scheduled to have the pump replaced but he moved the replacement date to (b)(6) because there is supposed to be another year left before eos (end of service).The patient was redirected to their healthcare provider to further address the issue.Additional information received from the healthcare provider confirmed that the patient did not have any exposure to emi, mri or magnets and believed that the pump was malfunctioning.The healthcare provider was transferred to the national answering service to page a company representative.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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 received reported that the symptoms the patient experienced related to the motor stall was unbelievable pain, withdrawals, dry heaves, ¿paang.¿, high blood pressure (179/118).The actions and interventions taken to resolve the issue was the pump was replaced (b)(6) 2023.The physician kept the defective device.
|
|
Search Alerts/Recalls
|
|
|