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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Twitching (2172); Irritability (2421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 24-feb-2017, 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

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding an implanted pump system.The pump was used to deliver gablofen (baclofen) 2000mcg/ml at 550.1mcg/day.It was reported that, one week prior to the report date, the patient reported withdrawal symptoms.The patient experienced increased spasticity and withdrawal symptoms of itching, twitching, and irritability.On (b)(6) 2023, surgery was done to explore the catheter.It was noted that the catheter was coiled in the pump pocket, but this was not the main issue.When the doctor went over to the midline back incision, it was noted that the anchor was the source of the problem.The anchor appeared to kink the catheter distal to the anchor.When this portion was retracted back and removed, the catheter was free-flowing.A new anchor was applied and a new pump segment and pump were implanted.The patient's medical history was asked but was unknown.At the time of this report, the issue was resolved and the patient status was "alive-no injury".No environmental, external, or patient factors that may have led or contributed to the issue were reported.

Manufacturer Narrative

Continuation of d10: product id 8784 serial# (b)(6) implanted: (b)(6) 2022 explanted: 2023-03-11 product type catheter product id 8780 serial# (b)(6) implanted: (b)(6) 2015 explanted: 2023-03-11 product type catheter h3: analysis of the 8780 catheter revealed catheter body has significant twisting that may affect infusion; kink observed.Analysis of the 8784 catheter revealed catheter body has significant twisting that may affect infusion; kink observed.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: 16570356
• MDR Text Key: 311557671
• Report Number: 3004209178-2023-03707
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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 Expiration Date: 10/14/2022
• 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
• Initial Date Manufacturer Received: 03/11/2023
• Initial Date FDA Received: 03/18/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 116 KG