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

Model Number 8637-40

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: product id 8709sc lot# (b)(4; serial# (b)(4) implanted: (b)(6) 2010 explanted: (b)(6) 2023 product type catheter product id 8709sc lot# (b)(4).Serial# (b)(4).Implanted: (b)(6) 2010 explanted: (b)(6) 2023 other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4) ubd: 22-feb-2012, 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.

Event Description

On (b)(6) 2023 information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving baclofen (1,320 mcg/ml, 659.5 mcg), bupivacaine (22,000 mcg/ml, 10,982 mcg), droperidol (198 mcg/ml, 98.93 mcg) and morphine (1 ,923.6 mcg/hr, 3,850 mcg/ml) via an implantable pump.It was reported the patient's pump was replaced (b)(6) 2023 and the catheter was aspirated, too.There was a full system prime.The patient came into the emergency room on (b)(6) 2023 with withdrawal symptoms.The rep was called to read the pump.There were no reported environmental, external, or patient factors that may have led or contributed to the issue.Diagnostics / troubleshooting was unknown.The rep did read the pump.The interventions / actions taken to resolve the issue was unknown.Additional information was received from the company representative.The logs were requested but not provided.The cause of the patient going into withdrawal was unknown.The action that was taken to resolve the patient withdrawal was unknown.The information was confirmed by the hcp.On (b)(6) 2023, additional information was received from the manufacturer representative (rep).They reported the hcp aspirated the catheter through the catheter access port (cap) of the existing pump; the hcp felt like they were getting a lot of air bubbles with some cerebrospinal fluid (csf).The hcp elected to revise the pump segment.They sliced on new 8596sc for new 2-piece catheter.The pump settings were verified with another healthcare professional (hcp).

Manufacturer Narrative

Visual inspection of the sutureless connector (sc) identified {coring/tearing/cuts} in the cup of the connector.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: 16515918
• MDR Text Key: 311122535
• Report Number: 3004209178-2023-03255
• 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
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 78 KG