MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Inappropriate or Unexpected Reset (2959); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2022 |
Event Type
malfunction
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Event Description
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Information was received from a healthcare provider (hcp) regarding a patient receiving morphine (7 mg/ml at 4.26 mg/day) and bupivacaine (1.5 mg/ml at 0.913 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.It was reported that when attempting to update the pump, they encountered an alert, pump alarm, and message that the pump was in safe mode/pump defaulted to minimum rate, and pump reset due to firmware error 2c along with service codes 101 (pump reset occurred) and 87 (pump in safe mode).During the call, the hcp silenced the active alarm and then tried to program the pump to minimum rate mode, but they were still unable to update and saw the same service codes (101 and 87).The hcp then programmed the pump with myptm set up and the hcp was able to successfully update the pump.The hcp exited the application and interrogated the pump and there were no alerts or active alarms, and the pump settings were correct.The troubleshooting steps that were taken during the call resolved the reported issue.
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Manufacturer Narrative
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Concomitant medical products: product id a810 lot# serial# unknown product type software.Other relevant device(s) are: product id: a810, serial/lot #: unknown, 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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