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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)

Patient Problem Pain (1994)

Event Date 05/18/2023

Event Type  Injury  

Event Description

Information was received from a patient and a healthcare provider regarding a patient receiving dilaudid via an implantable pump.The indication for use was non-malignant pain.It was reported that the healthcare provider (hcp)stated that the patient was in the hospital and they did a ct scan.The hcp stated that on (b)(6) 2022 the patient had a motor stall and recovered.The hcp noted that they interrogated the pump two times today and saw a message that the pump was motor stalled and to wait 20 minutes and reinterrogate the pump.The manufacturer's technical services specialist (tss) had the hcp check the logs and it showed that there were no other motor stalls since that date.The hcp stated that they saw the last stall (b)(6) and had multiple motor stalls and recoveries.The hcp stated that the patient did initially see an alert on the ptm but stated that after they were able to give themselves a bolus and would not see the issue.The hcp interrogated the pump several times and a motor stall occurred popped up every time.Though waiting 15 minutes the motor star recovery was not seen and tss warm transferred the hcp over to mobility to get tablet logs.It was worth noting that the patient said that they did not hear an audible alarm and they were in the hospital on (b)(6) and had a cat scan and no mri.The tablet states that the pump is stalled but in the logs it shows that it's recovered.The hcp called back for a third time and stated that they were expecting 4.1 milliliters of drug and got back 9ml's.Tss was going to wait for the tablet logs and redirected the nurse to speak to the surgeon for potential pump replacement if a motor stall recovery was not seen.The hcp stated that the patient had a little increase in pain but nothing substantial.The issue was not resolved through troubleshooting.

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.

Event Description

Additional information received reported that the pump had not been audibly alarming but there is an alert for a motor stall when reading the pump today.The caller stated that there is no motor stall in pump logs that he can see.They are shutting this pump off and it will be replaced in september 2023.The caller was given password 3532 and it was discussed this is permanent.The pump was showing an active motor stall when interrogated but the logs show no motor stall.It shows previous stalls and recoveries and the last log related to motor stalls was a recovery.

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
• 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: 17244121
• MDR Text Key: 318779992
• Report Number: 3004209178-2023-12001
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• 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: 08/01/2023
• Date Device Manufactured: 05/24/2019
• 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
• Patient Age: 70 YR
• Patient Sex: Female