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 09/26/2022

Event Type  malfunction  

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

(b)(6)2022 mpxr 996889, attachments x2 (con, rep, for): information was received from multiple sources (patient, manufacturer representative, foreign) regarding a patient who was receiving baclofen with concentration 2000.0 mcg/ml at a dose rate of 125.6 mcg/day) via an implantable pump.It was reported that the patient's pump started to alarm indicating a critical alarm.After performing device telemetry, two alert messages appeared with service code 234 reporting pump motor stoppage for more than 48 hours (692 hours on telemetry day) and service code 232.As per the logs provided, a critical alarm regarding motor stall occurred on (b)(6) 2022 followed by a critical alarm on (b)(6) 2022 regarding duration of motor stall exceeding 48 hours.  regarding factors that may have led or contributed to the issue, it was noted that the patient underwent an mri (magnetic resonance imaging) in (b)(6) 2022.Telemetry was performed, but the alerts still appeared and the alarm also continued to beep.  the issue was not resolved as of (b)(6) 2022.It was indicated as having been asked if there was any patient symptoms or complications associated with the event, but this was unknown.  it was indicated that no medical or surgical intervention was needed to prevent a permanent impairment of a function.  the patient did not require hospitalization.The patient was without injury regarding their status as of (b)(6) 2022.  the patient's medical history, weight, and age at the time of the event was unknown.

Event Description

Additional information was received from the foreign manufacturer's representative (rep) on 2022-oct-27.It was reported that the patient's pump returned to normal operation on 2022-oct-25 at 11:37 am when telemetry of the pump was performed.

Manufacturer Narrative

Device code (b)(4) removed to reflect the information received on (b)(6) 2022 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: 15674325
• MDR Text Key: 306803902
• Report Number: 3004209178-2022-14001
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 10/29/2022
• Date Device Manufactured: 01/12/2021
• 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 Sex: Female