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 Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving lioresal (baclofen) of an unknown concentration at an unknown dose rate via an implantable pump.It was reported that according to the physician, the actual volume in the pump was not the same as the expected / calculated volume.The catheter was changed and the issue still existed.There were no known factors that may have led or contributed to the issue.No further actions/intervention was taken to resolve the issue as of (b)(6) 2023.It was unknown if further surgical intervention was planned.The issue was not resolved as of (b)(6) 2023.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_cath lot# unknown product type catheter.Country of event is saudi arabia.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

Continuation of d10: product id neu_unknown_cath lot# / serial # unknown implanted: (b)(6)2022.Product type catheter h6 update: the previously applied device code a1405 is no longer applicable.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 was received from a foreign healthcare provider via a company representative on 2023-mar-31.The implant date of the pump (second implant) was (b)(6)2022.The catheter had been previously changed on (b)(6)2022.Regarding the volume discrepancy, the actual pump reservoir volume was 2.4 ml and the expected pump reservoir volume was near 8 ml.Further diagnostic testing/troubleshooting included a pump refill made on 2023-mar-19, and once the patient came back they were to aspirate and check the result and compare.Then an x-ray was and other plans were to be made if needed.The cause of the volume discrepancy was unknown.The catheter that had been explanted was discarded by the healthcare provider.The status of the pump was unclear as they were not sure yet if the pump will be explanted.It was further noted that they could not decide now to explant the pump, but a decision would be made after a full investigation.

Event Description

Additional information was received from a foreign healthcare provider via a company representative.The pump model number was 8637-20.The serial number was not yet available.The model number of the catheter was 8781.A pump refill was performed on (b)(6)2023, and since the last refill the pump was functioning properly.Therefore, the physician decided not to take any further action for now.

Manufacturer Narrative

Continuation of d10: product id 8781 serial # / lot# unknown product type catheter 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.

• 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: 16573097
• MDR Text Key: 311587605
• Report Number: 2182207-2023-00494
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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,Followup
• Report Date: 05/11/2023

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
• 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
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 03/31/2023; 05/11/2023
• Supplement Dates FDA Received: 04/04/2023; 05/11/2023
• 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 H10....; SEE H10....; SEE H10....
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 82 KG