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 Problems Muscular Rigidity (1968); Pain (1994)

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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

Information was received from a foreign consumer via a manufacturer's representative regarding a patient receiving lioresal (unknown concentration at 170 mcg/day) via an implantable infusion pump.It was reported the patient heard a 3 beep tone alarm every hour, thinking that it might be the pump.The event date was reported to be (b)(6) 2021.The patient also mentioned mild pain in both legs due to rigidity.The pump was interrogated with the clinician tablet to check the configuration, reservoir, logs, and alarms alerts.Everything looked normal, with no alerts shown.After checking the configuration of the pump, it was updated with no changes and then they waited for the beep to sound again, but only the patient could hear it.It was stated there were no contributing factors to the issue.The issue was not resolved.No medical/surgical intervention nor hospitalization was required.The patient status was alive - no injury.Further complications were not reported.An image of the tablet screen showing pump logs was provided; no anomalies in the logs were identified.Additional information was received from a foreign healthcare provider via a company representative on 2021-oct-27.No troubleshooting had been performed related to the patient¿s symptoms.The cause of the patient¿s symptoms had not been identified.No further actions were taken to resolve the patient¿s symptoms.Additional information was received from a foreign consumer via a manufacturer's representative (rep) on (b)(6) 2022.It was reported that the patient continued to hear a 3 tone alarm every hour.The patient provided the rep with an audio recording where they could hear the pump alarming.However, the pump was interrogated with the clinician programmer and everything seemed normal.The patient also reported pain and increased spasticity in their legs.It was noted that the patient had a catheter that was implanted 22 years prior.No actions/interventions were taken at the time of the report to resolve the issue.No medical/surgical intervention occurred nor was the patient hospitalized.The issue was not considered resolved.The patient's status was listed as "alive - no injury".The pump administered lioresal with concentration 500 mcg/ml at a dose rate of 170.25 mcg/day.

• 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: 18699903
• MDR Text Key: 335545814
• Report Number: 3004209178-2024-04652
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• 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: 10/18/2021
• Date Device Manufactured: 01/15/2016
• 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 Sex: Female