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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Data Problem (3196)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Diaphoresis (2452)

Event Date 11/29/2023

Event Type  Injury  

Event Description

Information was received from a consumer (con) via a company representative (rep) regarding a patient receiving morphine 5mg/ml via implantable pump.The indication use was for spinal pain.The company representative (rep) reported that the patient came in (b)(6) 2023 for refill and 23 ccs were aspirated when expected volume was 4 ccs.Additionally, the patient had a magnetic resonance imaging (mri) in (b)(6) 2023, but motor stall recovery was logged an hour after the scan.The patient reported nausea and sweating symptoms two weeks ago.They did not mention if pump was checked as a result.

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 was received from the manufacturer representative.It was reported that the cause of the inability to aspirate the catheter was determined during the case when the pump pocket was examined.It was determined there was a small kink in the cat heter just distal of the pump connector, which was taken care of when the physician straightened out the catheter, aspirated the cap chamber, and placed the pump along with catheter back into the pump pocket.It was determined that the kink in the catheter was the reason why there was so much of a discrepancy.A catheter revision was not performed because there was nothing wrong with the catheter, just a positional error that was corrected during the time of the surgery.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2023 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.

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative (rep) reporting that the pump was unable to be aspirated due to a possible kink in the catheter or some occurrence that had happened to the catheter.There was a large discrepancy when the hcp was exchanging out medications and noticed there was almost 20ml extra that was in the pump when there should have only been 4ml.Patient reported at the end of october/early november that they were experiencing sweats, increased pain, nausea, and some vomiting.It was reported that patient had a motor stall during mri but that it recovered about 20 minutes after the mri was done.A catheter access port (cap) study was then performed to ensure the catheter wasn't kinked and that was unsuccessful as the hcp was unable to withdrawal any fluid.A catheter revision was scheduled for (b)(6) 2023 to identify the issue and correct it.The issue was not resolved at the time of this report.The patient's status was "alive-no injury" and the patient's weight and medical history were asked but unknown and would not be made available for this report.

Manufacturer Narrative

Continuation of d10: product id 8780 serial# (b)(6) implanted: (b)(6) 2023 product type.Catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #:(b)(6), ubd:2024-11-02 , udi#:(b)(4).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 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: 18244116
• MDR Text Key: 329441273
• Report Number: 3004209178-2023-24813
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• UDI-Public: 00763000634100
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 12/21/2023
• Date Device Manufactured: 02/16/2023
• 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...."
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female