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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problems Seroma (2069); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2023

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding an implanted infusion pump for non-malignant pain.The pump was used to deliver hydromorphone 15mg/ml, unknown baclofen 100mcg/ml, and bupivacaine 7.5mg/ml.Dose information was unknown.It was reported that the patient had a refill on 2023-12-29.The refill was not done under fluoroscopy.The patient went back in on 2024-01-05 because he felt fluid build-up around the pump.At this time, they aspirated and got back clear fluid around the pump and filled the pump with saline.The patient went back in on 2024-01-11 to get filled with medication.16ml was expected back but they were only able to aspirate 1ml.It was noted that there were no prior volume discrepancies.The physician had asked if the pump could be leaking out of the septum.The physician had only used medtronic refill kits.The fluid was not tested.A dye study was attempted, but the catheter could not be aspirated.The physician did not think that the patient was accessing his pump.It was also reported that the patient had been getting poor therapy since implant.At the time of this report, the pump was four months away from end of service (eos).Per the rep, it sounded like they would likely move forward with explanting the pump at the end of march.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6).Implanted: (b)(6) 2017.Explanted: product type catheter product id 8780 lot# serial# (b)(6).Implanted: (b)(6) 2017.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: 17-jul-2017, udi#: (b)(4).; product id: 8780, serial/lot #: (b)(6); ubd: 17-jul-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.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was from a healthcare provider (hcp) via a company representative (rep) stated that the pump will be removed and the catheter will be tied off.The cause of volume discrepancy/fluid build up around the pump/unable to aspirate/poor therapy was asked but unknown at this time.

Manufacturer Narrative

Pump serial number corrected to (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18768169
• MDR Text Key: 336118599
• Report Number: 3004209178-2024-05557
• Device Sequence Number: 1
• Product Code: LKK
• 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: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Date Device Manufactured: 01/08/2016
• 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 H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 60 KG