MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, distributor, foreign) regarding a patient who was receiving gabalon of an known concentration via an implantable pump for dyty dystonia.It was reported that pump in terrogation was performed at the intrathecal baclofen pump refilling, and the physician had seen the service code 112 regarding pump memory error via their clinician programmer tablet.The pump¿s memory was corrupted and a message appeared saying that the drug in formation could not be obtained.They were questioning why the service code 112 occurred and what should be done to resolve the issue.At the time of the report, technical services reviewed that the cause of the service code 112 alert could not be confirmed at the time of the report.It was reviewed that service code 112 means the infusion prescription table, where the pump stores infusion data like dose and rate, are invalid or corrupt.It was being considered that the most probable cause for this is due to memory corruption.It was further reviewed that when this alert is seen, it does not restrict the user from viewing or making therapy changes.Verifying the infusion settings, confirming all programming is correct, and updating the pump was being considered.It was being considered that the pump should continue to run normally.It was further reported that the clinician programmer tablet was used in another patient in the morning, and a refill could be performed normally.Furthermore, the same message appeared when the device was switched to an n¿vision and interrogated.It was noted that this was the first time it happened so far, and they would like to know the cause.It was indicated that there might be a problem inside the pump.There were no problems with the patient¿s spasticity, etc.The pump alarm was not sounding.Regarding etiology, the event/programming not possible was unrelated to drug, and unknown if related to the pump, programmer, or procedure.Additional information was received from a foreign healthcare provider via a distributor on 2023-nov-28.The physician reported that the patient's pump had been interrogated again, and the same code 112 was displayed.However, the original data was entered and updated according to the instructions.After performing the interrogation again, the display was normal.The patient's condition was also reported to be good.The cause was unknown, but the device was functioning normally.The outcome of the event as of 2023-nov-27 was recovered.Regarding the programming not possible, the causal relationship of the event to the pump, catheter, programmer, and procedure was indicated as none.The daily dose rate of gabalon was 440 mcg/day.

Manufacturer Narrative

Continuation of d10: product id a810 lot# serial# unknown product type software product id 8870 serial# unknown implanted: explanted: product type software section d information references the main component of the system.Other relevant device(s) are: product id: a810, serial/lot #: unknown, ubd: unknown, udi#: unknown; product id: 8870, serial/lot #: unknown, ubd: unknown, udi#: 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.

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 was received from a foreign healthcare provider (hcp) via a distributer who reported the implant date of the pump was (b)(6) 2017.The software application version was asked, but unknown.The 8870 model software version was asked, but unknown.It was unknown if any relevant issues/messages were noted in the logs.The devices were still in use.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18314542
• MDR Text Key: 330943495
• Report Number: 2182207-2023-02747
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10....