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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Migration or Expulsion of Device (1395)

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Sepsis (2067); Urinary Tract Infection (2120); Loss of consciousness (2418); Decreased Respiratory Rate (2485); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780 , serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 29-jan-2022, udi#: (b)(4).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 company representative regarding a patient receiving dilaudid (10 mg/ml at 7 mg/day) via an implanted pump.It was reported that the patient had a pump refill done at 8:30 a.M.On (b)(6) 2022.The patient returned to the office at 10:30 unresponsive and his breathing was suppressed.An ambulance was called, narcan was administered, the patient became conscious, and the medical staff took him to the closest hospital for evaluation and monitoring.There were no expressed environmental, external, or patient factors that may have led or contributed to the issue.The patient returned to the office the following week for a reservoir aspiration to compare the actual versus the expected volumes.The reservoir was found to be short by approximately 7 ml.The drug aspirated was then placed back into the reservoir and a pump replacement surgery was scheduled.During the procedure, the pump pocket was opened and contained the entire catheter with the pump inside the pocket.None of the catheter was in the spine.The pump pocket was also dry per the hcp.He had expected to see some fluid if the catheter tip was in the pocket, so he was concerned of a pump malfunction.The pump and catheter were replaced, and the issue was noted to be resolved.It was noted that while in the hospital, post pump and catheter replacement, the patient had kidney failure, uti (urinary tract infection), sepsis, and stomach bleeding.The patient was moved to the icu (intensive care unit) and was recovering.His new pump was currently set to minimum rate.

Manufacturer Narrative

H3: analysis of pump (s/n:(b)(6)) identified no anomalies.Analysis of catheter (s/n: (b)(6)) identified no anomalies.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: 13633222
• MDR Text Key: 290060143
• Report Number: 3004209178-2022-02624
• 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,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• 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: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male