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

Model Number 8637-40

Device Problems Failure to Disconnect (2541); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (500 mcg/ml at 125 mcg/day) via an implanted pump.It was reported that the managing provider and the patient¿s family noted a change in symptoms/return of symptoms and changing the pump dosing did not improve the symptoms.The hcp team was unable to aspirate the catheter while in the office.The patient was put on oral medication until she could be scheduled for surgery.During the procedure, the doctor aspirated the catheter.He collected over 1 cc of fluid.At that point, the doctor believed the issue was related to the pump, so the plan was to only replace the pump.However, the physician had difficulty removing the sutureless connector from the pump and had to cut the catheter to explant the pump.At that point, he decided to attempt to aspirate again from the catheter, and he was unable to aspirate and viewed an unexpected amount of catheter in the abdomen.He then decided to re-drape the patient, position her laterally, and replace the full catheter.During the procedure, the pump and catheter were replaced.There were no known environmental, external, or patient factors that may have led or contributed to the issue.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 15-mar-2020, 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: 15587060
• MDR Text Key: 301560948
• Report Number: 3004209178-2022-13250
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• 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: 10/06/2022
• Date Device Manufactured: 02/08/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female