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

Model Number 8637-20

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 09/30/2020

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 consumer regarding a patient receiving intrathecal compounded morphine 20 mg/ml at 1.598 mg/day and bupivacaine 10 mg/ml at 0.799 mg/day via an implanted pump.It was reported a non-critical alarm started on (b)(6) 2020.It was noted the patient¿s healthcare provider (hcp) was closed for covid then went bankrupt and the patient found a new doctor that did not work with company representatives (rep).The patient had an appointment on (b)(6) 2020 but did not think it would result in a refill.The patient was redirected to the hcp to discuss the pump alarm and refill even if saline.Pentec contact information and physician listings were emailed to the patient and an email to the area reps was sent to help the patient find someone to refill the pump.Patient symptoms were not reported.Additional information was received from a consumer via a rep on 2020-oct-02 indicated the patient was beyond his refill date and the pump was emitting a non-critical alarm.The patient did not schedule a refill prior to a refill date.The rep was working with a clinical specialist to get the patient established at an office and secure a refill.Environmental/external/patient factors that may have led or contributed to the issue included patient compliance.The issue was not resolved and the time of this report and the patient¿s status was ¿alive- no injury.¿ the patient¿s weight and medical history were asked and would not be made available (legal/confidential reason).No further complications were reported.

Event Description

The rep reported that the cause of the non-critical alarm was low reservoir alarm.Actions taken to resolve the issue included refilling the pump.The event was resolved.

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.

• 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: 10635643
• MDR Text Key: 210088681
• Report Number: 3004209178-2020-17326
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/10/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR