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

Model Number 8637-40

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Headache (1880); Incontinence (1928); Muscle Weakness (1967); Numbness (2415)

Event Date 02/03/2023

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving lioresal (baclofen) with concentration 2000 mcg/ml via an implantable pump for unknown indications for use.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.The patient's medical history included multiple sclerosis.It was reported that the patient experienced intrathecal baclofen pump overdose three days post implant.A call was received from a healthcare provider on (b)(6) 2023 to advise regarding patient discharge home after implant on (b)(6) 2023.It was indicated that 3 days post op (b)(6) 2023, the patient had been admitted to hospital with headache, urinary incontinence, lower limb weakness, and numbness.A spinal scan was completed and findings were normal.Interventions taken included investigations and reduction of baclofen dose.The lioresal (concentration 2000mcg/ml) dose rate of 150 mcg/day was reduced over time.No surgical intervention occurred and no surgical intervention was planned.The patient was now currently on a minimum dose rate and all symptoms had resolved.There were no known factors that may have led or contributed to the issue.The issue was resolved as of (b)(6) 2023.The patient was without injury regarding their status as of (b)(6) 2023.The patient's age at the time of the event was 49 years and 10 months.The patient's weight at the time of the event was unknown.

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot# 0224626681, 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.

• 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: 16382013
• MDR Text Key: 309610625
• Report Number: 3004209178-2023-02160
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• 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: 02/14/2023
• Date Device Manufactured: 08/11/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male