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

Model Number 8637-40

Device Problem Protective Measures Problem (3015)

Patient Problem Muscle Spasm(s) (1966)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving an unknown drug with an unknown concentration at a dose of 276.2 mcg/day via an implantable pump.The indication for use was not provided.It was reported that the patient reported the pump alarm was going off.When the hcp saw the patient it was found that the pump had gone into safe mode delivering only 18 mcg/day.It was noted that the pump elective replacement indicator (eri) was 37 months, and that the patient had been on a stable dose of 276.2 mcg/day for the past couple of years with the last refill in (b)(6) 2018.It was noted that the patient had some spasms but no serious withdrawal symptoms.The hcp put the dose back to the previous dose and two days later the pump was okay and working well, and the patient's symptoms had resolved.It was confirmed that the patient denied any exposure to magnet, mri (magnetic resonance imaging) or similar.No further complications were reported or anticipated.

Manufacturer Narrative

A4: reported "approximately 80-90 kg" d6: implant date reported as "(b)(6) 2015" with no specified date.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 follow-up.It was clarified that the alarm/safe mode began on (b)(6) 2018 and the manufacturer representative was notified the next morning.It was confirmed that no reset occurred.The pump was reprogrammed with the previous dose and was checked to confirm that it was continuing correctly.The drug in the pump at the time of the event was baclofen [3000 mcg/ml] at a dose of 276.2 mcg/day.It was also reported that the patient was seen for a refill on (b)(6) 2019 and there were no reported issues and the pump was working fine as expected with optimal symptom control at the same dose.

• 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: 8043613
• MDR Text Key: 128249090
• Report Number: 3004209178-2018-24807
• 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
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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: 01/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR