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

Model Number 8637-40

Device Problems Filling Problem (1233); Excess Flow or Over-Infusion (1311)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/27/2024

Event Type  Injury  

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

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen (50 mcg/ml at 2.499 mcg/day) and morphine (10 mg/ml at 0.5 mg/day) via an implantable pump.It was reported that difficulty occurred when emptying and filling the pump.  it was further reported that there was a difference between the remaining pump reservoir volume and the sampled volume (3 ml instead of 8ml).  the pump emptied in 8 hours equating to overdose.   it was indicated that 40 ml was filled in the morning and there was only 21 ml remaining at the end of the day even if the dose was only 0.5 5mg/day.  the date of pump implant was unknown.  there were no known factors that may have led or contributed to the issue.  a surgeon indicated on (b)(6) 2024 that they would retire the pump.  pump explant was planned to occur on (b)(6) 2024.  it was unknown if the issue was resolved as of (b)(6) 2024.  the patient's medical history and weight at the time of the event were unknown or would not be made available.

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 a foreign healthcare provider (hcp) via a company representative (rep).It was reported that the patient went in for a filling of their intrathecal pump.When the patient returned home by ambulance, the paramedics found a comatose patient with signs of respiratory distress.After inquiry, the final dose of morphine administered was 600mg.There was a suspicion of leakage from the pump.The patient was in a coma for several days with real risk of death.A material ablation under general anesthesia occurred on (b)(6) 2024.The device was quarantined.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.It was unknown if any actions/interventions or diagnostics/troubleshooting were performed.It was unknown if the issue resolved at the time of the report, (b)(6) 2024.The patient's age, weight, medical history, and patient status were asked, but would not be made available.

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 a company representative (rep) reporting that the pump was not replaced.

Manufacturer Narrative

B5 correction:  the event narrative was updated for dose rate correction regarding "it was indicated that 40 ml was filled in the morning and there was only 21 ml remaining at the end of the day even if the dose was only 0.5 mg/day".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

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen (50 mcg/ml at 2.499 mcg/day) and morphine (10 mg/ml at 0.5 mg/day) via an implantable pump.It was reported that difficulty occurred when emptying and filling the pump.  it was further reported that there was a difference between the remaining pump reservoir volume and the sampled volume (3 ml instead of 8ml).  the pump emptied in 8 hours equating to overdose.   it was indicated that 40 ml was filled in the morning and there was only 21 ml remaining at the end of the day even if the dose was only 0.5 mg/day.  the date of pump implant was unknown.  there were no known factors that may have led or contributed to the issue.  a surgeon indicated on (b)(6) 2024 that they would retire the pump.  pump explant was planned to occur on (b)(6) 2024.  it was unknown if the issue was resolved as of (b)(6) 2024.  the patient's medical history and weight at the time of the event were unknown or would not be made available.

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 a foreign healthcare provider (hcp) via a company representative (rep).It was reported that the refill was on (b)(6) 2024 with the patient's symptoms starting on the same day.It was further clarified that the procedure of the material ablation was that the patient's pump was removed.The pump was explanted on (b)(6) 2024.A pump leak was not confirmed as the material seemed intact.The cause of the volume discrepancy and patient's symptoms was not identified.An injection of naloxone was performed to treat comatose symptoms.It was clarified that the nurse felt a resistance that was unusual when emptying/refilling the pump.The pump would be returned.

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 a company representative (rep) who reported that the naloxone resolved the patient's coma.The patient regained normal consciousness.

• 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: 19003467
• MDR Text Key: 338900941
• Report Number: 3004209178-2024-08108
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• 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: 03/29/2024
• Date Device Manufactured: 01/17/2022
• 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): Life Threatening; Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Female