MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
|
Back to Search Results |
|
Model Number 8637-20 |
Device Problem
Device Alarm System (1012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/26/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Information was received from a company representative (rep) regarding a patient receiving unknown intrathecal medication at unknown concentration/dose via an implantable pump for non-malignant pain and chronic low back pain.It was reported by the company rep that the healthcare provider (hcp) stated that a patient had been hearing alarm from pump every hour.The hcp stated patient had been hearing alarm since a few days after refill on (b)(6) 2024.When pump was read it did not show an active alarm.When logs were read there were no logs from refill in february until today when they updated the pump to change the interval from 1 to 6 hours.Hcp did alarm test for both alarms and patient said it was the non-critical alarm he was hearing.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Additional information received from a healthcare provider (hcp) via a manufacturer representative (rep) indicated that the patient's weight at the time of the event was unknown.There were no known external, environmental, or patient factors that may have caused or contributed to the event.The cause of the patient's pump alarming and event not in the logs was unknown and was "possibly user error" by the doctor when the pump refill was done.No actions/interventions were taken to resolve the event.At the time of this report, the pump was not currently alarming and the event had resolved.
|
|
Search Alerts/Recalls
|
|
|