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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted infusion pump.The pump was used to deliver fentanyl 11,400mcg/ml at a dose of 3933mcg/day and bupivacaine 27mg/ml at a dose of "9.3150mg/day.It was reported that an overdose occurred.The hcp was replacing the flowonix pump with a synchromed 2 pump, using the flowonix catheter.There was a lot of difficulty connecting the 8784 catheter to the flowonix catheter.When asked if the catheter was aspirated, the hcp indicated that he did not aspirate the catheter.When asked if he felt confident that 2ml or more were drained from the catheter, the hcp asked for the entire system to be primed.Per the reporter, they were using "telemetry from an email on the flowonix pump" and transferring that telemetry to the new pump.It was noted that the reporter had never seen flowonix telemetry before.The rep looked at the concentration and daily dose and programmed the new pump for that.The rep then mentioned to the doctor that "that seems high", so the doctor instructed them to "decrease it by 10%", so the rep did."89,100mcg/ml" was noted.The rep reviewed all of the telemetry with the doctor and the hit "update" and started the pump.The rep then left the hospital and decided to "check again".The rep checked the telemetry, noticed the dose was 3933mcg/day, realized the mistake and returned to the hospital.It was noted that there was a 20 minute priming bolus, so the rep rushed back to the hospital.As soon as the rep connected to the pump, the patient "coded".The pump was immediately programmed to minimum rate per an anesthesiologist request.The rep was going to return the pump back to the patient's dose per flowonix telemetry, but did not due to the anesthesiologist request.The patient received narcan and "woke right up".The patient was kept overnight for observation.As of (b)(6) 2024, the issue was resolved and the patient status was "alive-no injury".The patient's weight and medical history were asked but were unknown.

Manufacturer Narrative

Continuation of d10: product type programmer, physician section d information references the main component of the system.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Continuation of d10: product id 8784, serial# (b)(6), implanted: (b)(6) 2024, product type catheter, product id a810, product type software.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the manufacturer representative (rep).The rep stated that they suggested the doctor take out the competitor¿s catheter and put in a manufacturer catheter, but the doctor did not want to do that.The cause of the difficulty connecting the catheter to the competitor¿s catheter was unknown, other than lack of use.They sliced an end of the catheter then cut it flush after they got it through the collet.The catheter length was obtained in an email of the telemetry from the managing office.The difficulty connecting the catheter to the competitor¿s catheter was resolved.The dose was initially set to 98,100mcg, but the rep was unsure of the exact time that the pump ran at that rate.The patient¿s medical history was unknown.The pump was set to minimum rate and would be slowly increased by the doctor later.

• 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: 18963695
• MDR Text Key: 338432695
• Report Number: 2182207-2024-02095
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• 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 H11...."
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male