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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Overdose (1988); Loss of consciousness (2418)

Event Date 02/25/2019

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 manufacturer representative on 2019-mar-10 regarding a patient receiving morphine (2000mcg/ml at 420.4mcg/day) and baclofen (1500mcg/ml at 315.3mcg/day) via an implanted infusion pump.The indication for use was intractable spasticity.It was reported that two weeks ago ((b)(6) 2019) the patient started having symptoms of difficulty breathing.They were asked by the managing physician to come in and have the dose reduced, and the wife refused.On (b)(6) 2019 the patient was taken to the emergency room (er) and then became unresponsive.The patient was given narcan and became alert and talking.It was noted that the environmental, external, or patient factors that may have led or contributed to the event included the patient's wife not bringing them in two weeks ago when they first presented with difficulty breathing.No diagnostics or troubleshooting were performed, and the patient's pump was lowered 20% after narcan was given in the er.The issue was considered resolved at the time of report.No surgical intervention occurred or was planned and the patient's status was alive - no injury.No further complications were reported or anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8417266
• MDR Text Key: 138684407
• Report Number: 3004209178-2019-05176
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2019
• Date Device Manufactured: 02/05/2018
• 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 Outcome(s): Other
• Patient Age: 56 YR