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

Model Number	8637-40
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Nausea (1970)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Information was received from a healthcare provider regarding a patient who was receiving baclofen and clonidine via an implantable pump for unknown indications for use.It was reported that the patient had been having increasing residuals over the last couple of refills and increasing spasticity.They were expecting 4.5 ml but got 10.2 ml.Technical services recommended performing a dye study.
Event or Problem Description
Additional information was received from a healthcare provider stated that the cause of the event was unknown.The patient was referred for surgical evaluation for possible catheter revision.Outcome: the issue was not resolved.
Additional 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.
Additional 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 or Problem Description
Additional information was received from a healthcare provider.It was reported that the healthcare provider (hcp) stated a patient came in to the emergency department feeling nauseous and worried that their pump is malfunctioning.The hcp stated the patient reported a volume discrepancy at refill last week and was concerned that their pump was under infusing.The manufacturer's technical services specialist (tss) provided the national answering service number to see if a manufacturer representative could interrogate pump.Tss was unable to find a current pump in registration but the hcp stated the patient for sure had the pump refilled last week.
Event or Problem Description
Additional information received from a patient representative indicated that the patient was not happy with their previous neurosurgeon and they were looking for a new doctor to manage the pump.The patient was told that they needed to contact the manufacturer and that they needed to have the pump replaced.At the time of this report, the patient did not have the pump implanted.
Additional 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 or Problem Description
Additional information received from a consumer (con) stated that he was hearing a constant humming noise that was very loud and disturbing that was coming from the pump.The pump had been failing for a few months.When they were expecting to remove 10 ml they were removing 20ml.The patient stated that he was meeting with the surgeon tomorrow to discuss replacement/revision of pump/catheter.The patient was upset because of hearing a loud annoying humming and not happy about being redirected to a managing physician.The agent reviewed and redirected the patient to a healthcare provider.The patient disconnected the call.No symptoms were reported.
Additional Manufacturer Narrative
H3.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.

• Brand Name: SYNCHROMED II
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20569571
• Report Number: 3004209178-2024-21234
• Device Sequence Number: 12568978
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/03/2024; 11/06/2024; 11/07/2024; 01/21/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/07/2024; 11/08/2024; 11/19/2024; 01/23/2025
• Date Device Manufactured: 02/19/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male