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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Data Problem (3196)

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

Event Date 05/08/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen (2000mcg/ml at 200mcg/day) via an implantable pump for unknown indications for use.It was reported that the company representative received a call from the healthcare provider stating the patient had magnetic resonance imaging (mri) performed and the pump stalled.Post mri, the pump motor stall recovered, but there were other alarms that occurred.Additional information was later received from a foreign healthcare provider.While she was interrogating the pump, it alarmed and a reset and safe state occurred.The pump was infusing at minimum rate mode.At the time of the report technical services had the physician re-interrogate the pump, and they selected workflow guide off to check all fields for accuracy.The physician updated the infusion rate and attempted to update but was unsuccessful.Technical services then had the physician enter patient activated (pa) dosing with the simple continuous and update the pump, and it then had accurately updated.The physician then re-interrogated the pump and disabled the pa dosing and the pump again updated successfully.The programming was correct.

Manufacturer Narrative

Continuation of d10: product id: 8870, serial# unknown, product type: software.Section d information references the main component of the system.Other relevant device(s) are: 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.

Event Description

Additional information was received from a foreign healthcare provider via a company representative.The age of the patient was 63 years and 8 months.A firmware error was noted, and the pump alarmed and defaulted to a minimum rate.Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient had an mri (magnetic resonance imaging) prior to the first pump motor stall and motor stall recovery.The pump was interrogated and the logs were read.As per the logs, the following occurred: (b)(6) 2022 10:10 critical alarm ¿ pump motor stall, (b)(6) 2022 10:46 pump motor stall recovery, (b)(6) 2022 11:40 critical alarm ¿ pump reset due to firmware error, (b)(6) 2022 11:40 critical alarm ¿ pump reset, (b)(6) 2022 11:40 critical alarm ¿ pump defaulted to minimum rate, (b)(6) 2022 12:55 pump motor stall recovery, (b)(6) 2022 12:55 programming step, (b)(6) 2022 12:55 critical alarm ¿ pump defaulted to minimum rate, and (b)(6) 2022 12:55 event status cleared.The healthcare provider had spoke with technical services for support and the issue was resolved.No surgical intervention occurred and no surgical intervention was planned.The patient was without injury regarding their status as of (b)(6) 2022.The patient¿s medical history and weight at the time of the event was unknown or would not be provided.The pump administered baclofen (2000 mcg/ml) at a dose rate of 199.8 mcg/day.

Manufacturer Narrative

Continuation of d10: product id: 8870, software version: 1.1.342, product type: software.H10: this device issue is known and documented in the labeling per ma04279a071 ¿ n¿vision clinician programmer with software synchromed ii infusion systems.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 via a company representative.The version of clinician programmer software used at the time of the event was 1.1.342.

• 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: 14347314
• MDR Text Key: 291323645
• Report Number: 2182207-2022-00770
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2022
• Date Device Manufactured: 03/23/2020
• 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
• Patient Age: 63 YR
• Patient Sex: Female