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

Model Number 8637-40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fatigue (1849); Malaise (2359); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/04/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving an unknown medication of an unknown concentration at an unknown dose rate via an implantable pump.It was initially reported on (b)(6) 2022 that a pump replacement was performed and the patient became unwell later on.The date (b)(6) 2022 is considered an approximate date of event (specific month and year known only).The pump didn¿t alarm and everything went well surgically.They have read the logs and wanted to know what the codes mean.As per the log provided the following codes were displayed on (b)(6) 2022 at 11:41 regarding programming steps: 16, 26, 23, 24, 14, 21, and 22.At the time of the report, technical services reviewed that the event log codes provided were all related to programming steps that take place during a programming session of the pump.Technical services further noted that all the programming steps (event log codes) are automatically logged in the event logs when a programming session is performed.It was further reviewed that regarding the codes provided there was no action required, and that these programming steps are always logged as part of the programming session.Additional information was received from a foreign healthcare provider via a company representative on (b)(6) 2022.The pump replacement performed on (b)(6) 2022 was a standard pump replacement; there was no suspicious issue with the pump that was replaced.The patient was unwell in recovery from a general anesthetic.The hospital did not know the reason the patient was unwell and reported as drowsy.The pump was not alarming nor was there any issues surgically implanting the replacement pump.It was further noted that although they are familiar and use the tablet programmer regularly, the report logs for the tablet look differently from the envision they wanted to clarify what the logs meant.The baclofen nurse thought that potentially they did not fully manage to aspirate the catheter, which is their normal practice, therefore the patient may have had an overdose of baclofen but they didn¿t know this for sure but was a valid reason.They programmed pump replacement as no drug in path and aspirated old drug from catheter.All trouble shooting was on the day of implant ((b)(6) 2022).They stopped the pump temporarily and monitored the patient.They also removed the baclofen from the pump and sent the baclofen off for testing.All was well with the baclofen.Regarding the cause of the event, it was further noted that the nurse suspected they did not fully aspirate the old drug from the catheter as the reason.The event had resolved.The patient was monitored in the hospital as an in-patient overnight, and the pump was re-started the day after.They also took the patient¿s dose down by 10% and the patient was well with no issues.The patient¿s medical history, age, and weight at the time of the event could not be provided.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath; product type: catheter.Product id: a810; product type: software.Other relevant device(s) are: product id: neu_unknown_cath.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

B2 correction: regarding outcome attributed to the adverse event, other was previously indicated in the initial report in error, and hospitalization should have been indicated instead.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 model of catheter associated with the event was an ascenda 8780 that had been implanted in (b)(6) 2016 (specific month and year known only).The healthcare provider did not have the serial number of the catheter.The patient was well and receiving therapy with no issue with the pump or catheter.

Manufacturer Narrative

Continuation of d10: product id: 8780, serial#: unknown, implanted: 2016 (b)(6), (approximate date), product type: catheter.Product id: a810, serial#: unknown, product type: software.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14197451
• MDR Text Key: 290464412
• Report Number: 3004209178-2022-05220
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• 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: 04/26/2022
• Date Device Manufactured: 10/22/2021
• 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 Outcome(s): Hospitalization; Other
• Patient Sex: Female