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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Noise, Audible (3273)

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

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving compounded baclofen (2000 mcg/ml at 500,1 mcg/day) via an implantable pump for unknown indications for use.It was reported that there was a critical alarm caused by a sudden motor stall in the morning on (b)(6) 2021. it was indicated that the pump was under normal use in a home situation, and that there was no emi or other identifiable cause. it was also noted that the medical team and patient heard a ticking noise that was not there before. the patient did not perceive any withdrawal symptoms and felt okay. the logs were checked the same day, and the patient was kept under supervision in the hospital.They tried to program a single bolus multiple times that day to try to restart the motor as no recovery had occurred.The logs were also checked multiple times.At the end of the day the patient was admitted to the medium care unit because the medical team was afraid the patient would go into withdrawal.On (b)(6) 2021 the logs were checked again and still no recovery had occurred, but the patient was still doing fine.However, as there was still no recovery after 27 hours , confidence in the pump had disappeared and they didn't want to wait for the 48 hours to be up (as permanent damage to the pump can occur if the pump is stalled from more than 48 hours), so they immediately scheduled a replacement surgery.The new pump was started at the same concentration and daily dose as the old pump.The team reportedly found it strange that the patient didn't experience any withdrawal symptoms.The explanted pump was going to be returned.At the time of the report the issue was resolved and the patient status was alive without injury.

Manufacturer Narrative

H3: the pump was returned, and analysis found corrosion and/or wear and/or lubrication and stall due to shaft bearing.H6: all previously reported method, result, and conclusion codes no longer apply to this event.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
• MDR Report Key: 11325045
• MDR Text Key: 233313990
• Report Number: 3004209178-2021-02548
• 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: company representative,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 80