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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

Patient Problems Burning Sensation (2146); Ambulation Difficulties (2544)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal fentanyl 2,000 mcg/ml at 145 mcg/day via implanted pump for non-malignant pain.It was reported the patient came in for refill on (b)(6) 2024 and came back in on the date of this report to have the dose lowered.When the hcp interrogated the pump she got a bunch of error codes and was unable to update the pump (service codes 225, 231, 260, 259, 257- minimum rate mode, pump reset, settings unavailable, potential underdose, etc.).It was reported on (b)(6) 2024 her elective replacement indicator (eri) was set to (b)(6) 2028.It was noted now the eri was saying it was one month away.Technical services (tss) tried to verify what date these error codes were showing up in the logs and when the hcp went into logs to check, no time stamps or anything were showing up in logs.Tss calculated that reservoir volume of 16.2ml on (b)(6) 2024 with simple continuous flow rate should now be 15.475ml yet the reservoir volume was showing up as zero.It was repor ted there was no audible alarm and they were unable to get logs or update the pump.Tss had caller try to interrogate and pull logs with another programmer to rule out issue with programmer.The hcp used another programmer and error codes still occurred (service code 87: potential underdose or overdose, pump error has occurred, minimum rate, service code 101: pump reset occurred, service code 114: pump memory error, service code 117: potential underdose pump alarm settings unavailable, and 526) confirming programmer not the issue.Tss confirmed pump had reset and memory error occurred, settings have been wiped out.It was reported the patient had a non-invasive laser fat removal procedure last week ((b)(6) 2024) but otherwise nothing unusual as far as environment.The patient's pump was in her back above the right hip and she was laying on her back and laser was not directed at pump at all (in her stomach) but no shielding was done.The hcp confirmed the patient was not symptomatic (has had several falls, legs give out and burning sensation but that was not new as of last refill).Tss discussed sending pump in for analysis and emailing pictures of error codes/logs screen and considering replacement.Per the pump logs provided with a session date of (b)(6) 2024 the following alarm/alerts were occurring: service code 225: potential underdose or overdose, an error had occurred in the pump and the pump had reverted to minimum rate.Service code 231: pump reset occurred, service code: 260, pump alarm settings are not available, service code 259: pump memory error, service code: 527: the programmer time may be incorrect.Elective replacement showed february (1 month from the session date).Other service codes provided included: service code: 162: the application was closed while updating the pump.The pump state is unknown.The pump maybe stopped.It was also noted that the reservoir volume was incomplete.

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 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 healthcare provider (hcp) indicating that the patient's weight was 209.6 lbs at the time of the report.It was provided that the pump reservoir was not empty, the reservoir was accessed on (b)(6) 2024 16.5 ml obtained.The cause of the pump reset and memory error was reported as "unknown, but recently patient had abdominal laser procedure".It was reported that the issue was unresolved and they were unable to program pump on (b)(6) 2024 and on (b)(6) 2024 they removed fentanyl from the pump reservoir.Successful catheter access port (cap) aspiration was noted.It was also reported that a magnetic resonance imaging (mri) of the lumbar spine occurred on (b)(6) 2024 to consider pump replacement.The devices were currently still implanted as of this report.

• 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: 18812752
• MDR Text Key: 337633021
• Report Number: 3004209178-2024-06040
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2023
• 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: 02/05/2024
• Date Device Manufactured: 08/18/2021
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG