MAUDE Adverse Event Report: MDT 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 Problem Respiratory Distress (2045)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial #: (b)(4), implanted: (b)(6) 2016, product type: catheter.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 receiving compounded baclofen and morphine via an implanted pump.The indication for pump use was intractable spasticity.On (b)(6) 2018 it was reported that the patient had a dye study on (b)(6) 2018 to check for patency of the catheter.Afterwards, the doctor decided to increase the patient¿s dose by 25%.This morning ((b)(6) 2018) the doctor called to say the patient was in the hospital and intubated.No patient symptoms were reported.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be ¿maybe the 25% increase?¿.The doctor was going to decrease the dose.It was indicated that it was unknown if the issue was resolved at the time of the report and the hcp had no further information regarding the event.No surgical intervention occurred, and none was planned.The patient status was reported as ¿alive ¿ no injury¿.Additional information was received from the healthcare provider who reported that the symptoms the patient experienced related to the event was respiratory distress.The cause of the patient¿s symptoms was determined to be most likely baclofen sensitivity.The actions and interventions taken to resolve the patient¿s symptoms was the patient was hospitalized and the dose (rate) decreased.No further complications were reported or anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8240101
• MDR Text Key: 132808062
• Report Number: 3004209178-2019-00755
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• 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: 12/28/2018
• Date Device Manufactured: 06/06/2013
• 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): Hospitalization; Life Threatening
• Patient Age: 55 YR