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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503)

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

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving compounded baclofen with concentration 2000 mcg/ml at a dose rate of 376,1 mcg/day (flex dose rate) via an implantable pump.It was reported that the patient was hearing three times beeping of her pump every ten minutes.On (b)(6) 2020 another specialized nurse visited the patient for checkup and to read the pump logs.As per the logs a critical alarm regarding motor stall occurred on (b)(6) 2022 at 18:36 followed by a motor stall recovery on (b)(6) 2022 at 19:06.Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient drove in a taxi van with no iphone, and with the belt positioned on the wheelchair (not on their belly).During phone call, and after another an hour of contact, nothing more was to be heard.The patient did not experience any complaints; therefore, no further actions were taken.No catheter issue was observed.No surgical intervention occurred and no surgical intervention was planned.The issue was resolved as of (b)(6) 2022.The patient was without injury regarding their status as of (b)(6) 2022.The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, lot#: unknown, product type: catheter.The date (b)(6) 2022 is considered an approximate date of implant (specific month and year known only).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 via a company representative.Earlier april, a critical alarm was reported by nurse practitioner for unplanned exposure to ems.This pump had another critical alarm (b)(6) 2022.As per the logs a pump motor stall occurred on (b)(6) 2022 at 14:43 followed by motor stall recovery the same day at 16:09.The times of the motor stalls corresponded completely with the time the patient was in the taxi, and in the alleged magnetic field of the safety belt.There was no increase in spasticity an no withdrawal symptoms.The patient was nervous though.The guidance of the residential group was to contact the taxi company, regarding how this can be prevented in the future.

• 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: 14215064
• MDR Text Key: 290575280
• Report Number: 3004209178-2022-05278
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Date Device Manufactured: 12/20/2021
• 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
• Treatment: "SEE H10....".
• Patient Sex: Female