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

Model Number 8637-20

Device Problem Electromagnetic Interference (1194)

Patient Problem Muscular Rigidity (1968)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen with concentration 500 mcg/ml at a dose rate of 75.02 mcg/day via an implantable pump.It was reported that patient came in for scheduled pump refill appointment on (b)(6) 2023.It was noted that the patient mentioned a slight increase in spasticity since their last magnetic resonance imaging (mri) was performed on (b)(6) 2023.After the mri, the pump was not interrogated.The pump log showed a motor stopped (stall) from (b)(6) 2023 until interrogation on (b)(6) 2023.A pump alarm was never heard.The pump log also showed a critical alarm regarding the pump having been stopped longer than 48 hours on (b)(6) 2023(48 hours after the motor stall that occurred on (b)(6) 2023.However, the indicated residual volume and the aspirated residual volume were not conspicuous.The expected reservoir volume (erv) at refill on (b)(6) 2022 was 3.7 ml, and the actual reservoir volume (arv) aspirated was 3.8 ml.At a refill on (b)(6) 2022, erv was 3.4 ml, and arv was 3.2 ml.At a refill on (b)(6) 2023, erv was 3.5 ml, and arv was 4.4 ml.Regarding factors that may have led or contributed to the issue, mri as above was indicated.Diagnostic tests/troubleshooting performed included pump interrogation and pump refill.Regarding actions taken to resolve the issue, a gradual dose increase was planned, starting with 25 mcg/day as of (b)(6) 2023.It was unknown if the issue was resolved as of (b)(6) 2023.The patient was without injury regarding their status as of (b)(6) 2023.No surgical intervention occurred and no surgical intervention was planned.The patient was 45 years old and 10 months.The patient's medical history and weight at the time of the event was unknown or would not be made available.Additional information was received from a company representative on (b)(6) 2023.It was indicated that telemetry mode seems to be the clarification.

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.

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 was received from a foreign healthcare provider via a company representative.There was no clear determination regarding the cause of the slight increase of spasticity.Regarding actions taken/planned to resolve the increased spasticity, it was noted that the center was in the process of gradually increasing the dose and adjusting it to the patient¿s needs.The motor stall event had resolved and the pump remained in service.

• 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: 16780822
• MDR Text Key: 314005264
• Report Number: 3004209178-2023-05354
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• 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: 04/26/2023
• Date Device Manufactured: 06/03/2021
• 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 Age: 45 YR
• Patient Sex: Male