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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# unknown, product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient who was receiving baclofen 2000 mcg/ml; 500 mcg via an implantable pump.Indication for use was intractable spasticity and spinal cord injury/spinal cord disease.The date of the event was (b)(6) 2019.It was reported a low reservoir alarm occurred on (b)(6) 2019, and an empty reservoir alarm occurred on (b)(6) 2019.No withdrawal symptoms were reported by the patient.The patient had impaired hearing, which may have contributed to him not hearing the low reservoir alarm which started on 1/10.The pump was refilled.The expected residual volume at time of refill on 1/15 was 0.0 ml; the actual residual volume equaled 4.0 ml.The volume discrepancy was documented and will continue to be noted at future refills.The low reservoir alarm date at the last refill on (b)(6) 2018, was (b)(6) 2019, but read as (b)(6) 2019, at the refill on (b)(6) 2019.It was reviewed that the alarm date will read as the current date if there is an active alarm.No diagnostics/troubleshooting were performed.Patient status was alive - no injury.The issue was resolved.Patient weight and medical history were asked but were unknown.No further complications were reported.

Manufacturer Narrative

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 from a healthcare professional (hcp) via a company representative.The cause of the empty reservoir alarm was determined that despite the residual volume of 4ml the empty reservoir alarm was expected to go off on (b)(6) 2019 based on the programmed infusion rate and volume filled on (b)(6) 2018.The pump was filled and the setting was updated.The empty reservoir alarm has been resolved.The clinician programmer (8840) serial number was unknown.

• 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: 8260113
• MDR Text Key: 133847736
• Report Number: 3004209178-2019-01271
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR