MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Inappropriate or Unexpected Reset (2959); Appropriate Term/Code Not Available (3191); Data Problem (3196)

Patient Problems Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: a810, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving baclofen (1000 mcg/ml at 280 mcg/day) via an implantable pump for an unknown indication for use.It was reported the patient was admitted to the emergency room (er) and in the past 72 hours (prior to (b)(6) 2021) had an increase in spasticity.The event date was reported to be (b)(6) 2021.The pump was interrogated and alerts were seen.On (b)(6) 2021, the pump had reset (firmware error) and went into minimum rate.The last time the patient had a refill was sometime back in november, and the patient had not been around any electromagnetic interference (emi) or magnetic resonance imaging (mri).Technical services reviewed the meaning of the error and provided guidance to silence the pump alarm, check/update the programming, and to update the pump.The patient was on oral baclofen at the time so they would probably start the patient on a low dose and titrate up.Additional information was received.The hcp attempted to follow the previous suggestion of silencing the alarm and updating the pump, but every time they went to tap the update button two alerts came back up (service code 101 [pump reset occurred] and service code 87 [pump in safe mode]) and then displayed a message that they could not update the pump due to the pending alarms.The hcp attempted multiple times to update the pump and the two alerts continued to populate on the screen.Technical services had the hcp ensure they were on the most recent version of the a810 application.Technical services then had the hcp start from the beginning home screen, tap active alarms, then silence (to which the hcp confirmed showed green which meant pending).Technical services then had the hcp go into the refill and adjust workflow, where the hcp stated they took the pump out of minimum rate then dropped the infusion to 75 mcg/day since the patient had been without medication since (b)(6) 2021 and was getting oral medication as well.Technical services then instructed the hcp to program a single bolus of the lowest amount and enable personal therapy manager (ptm) settings.Only then was the hcp able to successfully silence the alarm and update the pump.Following the successful update, the hcp checked the pump logs, re-interrogated, entered the workflow, disabled the ptm settings, and was able to successfully update the pump.The hcp confirmed there was no active alarm and troubleshooting resolved the issue.Further complications were not reported.Additional information was received.It was indicated the dose was upped to 224 mcg/day and there was a suggestion to reduce the oral dose to 10 mg/day.The patient would come in on (b)(6) 2021 for a final adjustment to 280 mcg/day and to stop or further reduce oral medication and discharge.The patient's tone was getting back to normal.It was also indicated the [pump] logs remained clear.A session report from (b)(6) 2021 at 1:13 pm was provided.The pump was in safe state and there was an alert indicating pump reset had occurred.The logs indicated pump reset, pump reset due to firmware error, and pump defaulted to minimum rate events occurred on (b)(6) 2021 at 6:06 am.A session report from (b)(6) 2021 at 2:08 pm was provided.The pump was in safe state and there was an alert indicating pump reset had occurred.A session report from (b)(6) 2021 at 2:22 pm was provided.The report showed the pump had been updated on (b)(6) 2021 at 2:39 pm.The report indicated changes were made in reservoir volume, infusion, single bolus, myptm setup, and silenced alarms.The report indicated that at the beginning of the session the pump was in safe state and there was an alert indicating pump reset had occurred, however, these alerts were no longer present after the pump had been updated.The logs indicated a pump defaulted to minimum rate event occurred on (b)(6) 2021 at 2:35 pm.After that alert, no other abnormal events were present in the logs.

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.

Manufacturer Narrative

H6: fdm/annex b updated to b17.Imf/annex f code f11 updated to f12.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 from a foreign user facility.It was reported the pump was replaced and would be returned.It was indicated there was no serious harm reported.

Manufacturer Narrative

H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Analysis confirmed a reset occurred but could not determine the cause.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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11196331
• MDR Text Key: 227766962
• Report Number: 3004209178-2021-00981
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention