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); Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Loss of consciousness (2418); Cognitive Changes (2551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2024

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted infusion pump for non-malignant pain.Per reported information on 2024-01-27, the pump was used to deliver fentanyl and unknown morphine.Dose and concentration information was not reported.Per reported information on 2024-01-28, the pump was used to deliver unknown baclofen 2mg/ml at 1.0266mg/day and unknown morphine 7mg/ml at 3.5930mg/day.On 2024-01-27, it reported that, per the emergency room (er) doctor, the patient came in with an altered mental status.The doctor thought that the pump was over infusing.The doctor was redirected to the national answering service to page a rep.Per information received on 2024-01-28, a pump issue and sepsis occurred.The patient experienced symptoms of overdose and symptoms of sepsis.In regards to environmental, external, or patient factors that may have led or contributed to the issue, it was noted that there was recent hip surgery completed in december very close to where the pump was located.The patient had a catheter dye study scheduled for 2024-01-31.The patient reportedly responded to narcan when first admitted, so a temporary stop to the pump was performed.A possible revision surgery was noted.It was also indicated that surgical intervention was planned but had not been scheduled.At the time of this report, the issue was not resolved and the patient status was "alive-no injury".Per information received on 2024-01-29, the patient's pump was "overdelivering medication", so they had to turn the pump off.The patient was not responding, so they turned it off and now the hcp wanted the pump to be turned back on.Additional information received on 2024-02-03 from a rep indicated that, at the time of this report, the rep was with the patient and was seeing a tube set alert.Technical services recommended continuing with the update to turn the pump back on.The rep clarified that the pump had been stopped on 2024-01-28 then turned back on 2024-01-29 and turned back off again on 2024-01-29.The pump was being turned back on 2024-02-03.A catheter access port (cap) study was done and "everything was fine".It was noted that the pump was filled with infumorph (morphine) but a bridge bolus was not done.The bridge bolus was intentionally skipped.The physician suspected that the wrong medication had been used to fill the pump, which was what caused the overdose symptoms.The physician cleared the catheter via the cap and withdrew all medication from the reservoir.He filled the pump with a higher concentration of medication than the suspected previous medication, which would slow the rate of infusion.He kept the patient at the hospital to observe for 48 hours to wait for all of the medication to clear the internal pump tubing.The reporter believed that the pump was filled with the wrong drug at the last refill and that's what led to the patient having symptoms because, within 48 hours of the refill, the patient was unresponsive.The physician elected not to do a system content removal procedure.Technical services reviewed that, based on the current flow rate, it would take 15-23 hours to infuse the remaining medication.The patient was to remain in the hospital for observation.Later on 2024-02-03, it was reported that they now planned to set the medication to 10mg/ml at 1.5mg/day.Technical services reviewed that if the pump tubing was 0.289ml, it would take 1.9 days for the medication to infuse.The patient was to be monitored for 48 hours.Additional information received on 2024-02-07 indicated that no volume discrepancies occurred.It was clarified that the medications at the time of the event were morphine 7mg/ml and baclofen 2mg/ml.The results of the previously reported catheter dye study were normal.In regards to the cause of the overdose, the doctor suspected that the medication was "bad" and was possibly a mislabeled batch from the pharmacy.In regards to the previous report of sepsis, an infection occurred.The type/location of the infection was unknown.Surgical intervention was not planned or scheduled.At the time of this report, the event was resolved.Medications were taken out of the pump.Fresh morphine was added to the reservoir and infusion was resumed.The patient was monitored for 48 hours with no symptoms of overinfusion.Additional information received on 2024-02-14 indicated that the patient's pump was permanently stopped by the doctor.The patient's weight was 170 pounds and the patient's medical history included epilepsy and chronic pain.

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 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 received on 2024-02-26 from a manufacturer representative (rep) indicated that the patient was discharged from the hospital on (b)(6) 2024 after the refill with singly agent infumorph 10mg/ml at 1.5mg/day.The patient went back to the clinic on (b)(6) 2024 and had a refill with an unknown compounded drug.The patient later went back to the emergency room (er) on (b)(6) 2024 or (b)(6) 2024 with overdose symptoms.Narcan was administered and the pump was stopped.The reporter believed that the pump was permanently shut off.At the time of this report, the patient was unresponsive.

• 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: 18764546
• MDR Text Key: 336055561
• Report Number: 3004209178-2024-05515
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• 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: 02/26/2024
• Date Device Manufactured: 03/27/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 77 KG