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

Model Number 8637-40

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Information was received from a foreign consumer (con) via a manufacturer's representative (rep) regarding a patient who was receivi ng baclofen and a second medication for help with pain via an implantable pump.On 2022-apr-21, it was reported that the healthcare provider stated they were told the patient¿s pump alarmed three times yesterday ((b)(6) 2022), once at 8:45, a second time (exact time unknown), and then a third time at 10:45.The pump had been filled a week or two ago and was implanted in 2017.The healthcare provider was not with the patient.No patient symptoms were reported.Additional information was later received from a foreign patient and healthcare provider via a company representative on 2022-apr-21.The patient's pump alarmed three times on (b)(6) 2022 for one hour.The alarm heard was described as a tone of about 5 seconds each time.No further alarms had occurred since 10:45 am on (b)(6) 2022, which was the 3rd alarm.Environmental/external/patient factors that might have led or contributed to the issue was indicated as not applicable.No diagnostics/troubleshooting were performed.The patient was to be seen by their healthcare provider or representative within approximate a week.No surgical intervention occurred, and it was unknown if surgical intervention was planned.The issue was indicated as having resolved as of (b)(6) 2022.The patient was without injury regarding their status as of (b)(6) 2022.The patient's status was listed as "alive-no injury".The patient¿s medical history was unknown or would not be made available.Additional information was received from a foreign healthcare provider via a company representative on (b)(6) 2022.It was reported that the patient¿s pump was due to be filled on (b)(6) 2022, but the patient was hearing the pump alarm on (b)(6) 2022.The pump logs were checked and there were no events were listed on (b)(6) 2022.Programming steps were however noted in the logs, but these were attributed to patient's previous pump refills on (b)(6) 2022 and on (b)(6) 2022.The healthcare provider concluded that the patient was likely hearing something other than the pump.The issue was considered resolved through troubleshooting.The pump administered baclofen with concentration 300 mcg/ml at a dose rate of 249.78 mcg/day and bupivacaine with concentration 6000 mcg/ml at a dose rate of 4995.6 mcg/day.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.E1: the first name of the physician is unknown.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: 18707161
• MDR Text Key: 336442071
• Report Number: 3004209178-2024-04759
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• 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: 04/21/2022
• Date Device Manufactured: 05/15/2017
• 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