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

Model Number 8637-40

Device Problem Protective Measures Problem (3015)

Patient Problems Vomiting (2144); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient receiving baclofen 27mg/ml at min rate and morphine 50mg/ml at min rate.The indication for use was non-malignant pain.On (b)(6) 2019 the healthcare provider reported that the patient came in today to check on their pump since the patient was not feeling well.Per the healthcare provider the patient felt really bad, was throwing up, and thought they had a bug.The patient did go in for a ct scan because she thought she had ¿bugs¿.The healthcare provider stated that after reading the pump logs, it shows the pump went into safe state.There were no other anomalies that occurred prior or after the safe state message.The last refill the patient came in was on (b)(6) 2019.The healthcare provider stated that she pulled out 18ml for the pump which was what was expected.The healthcare provider programmed the pump out of minimum rate and was able to program as normal.The new settings programmed were baclofen 27mcg/ml at 2.7mcg/day and morphine 50mg/ml at 5mg/day.Troubleshooting resolved the issue and the healthcare provider would have the patient come back in monday and would titrate from there.No further complications were reported or anticipated regarding the event.

Event Description

Additional information was received from the healthcare provider on (b)(6) 2020 who reported that the date and time of the safe state message noted in the logs was (b)(6)2019.The date and time of the patient¿s ct scan was approximately (b)(6) 2019 as the patient was unsure.The cause for the safe state message was not determined.No further complications were reported or anticipated.

Manufacturer Narrative

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
• MDR Report Key: 9473254
• MDR Text Key: 184468402
• Report Number: 3004209178-2019-23846
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 68