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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Chills (2191); Therapeutic Response, Decreased (2271)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 8596sc, serial# (b)(4), implanted: (b)(6) 2016, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: 28-jul-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a clinical study on (b)(6) 2018 regarding a patient receiving compounded baclofen (1000mcg/ml at 77.9mcg/day), fentanyl (795.0 mcg/ml at 61.93mcg/day), and bupivacaine (5.0mg/ml at 0.3895 mg/day) via an implanted infusion pump.The indication for use was intractable spasticity.It was reported that the patient experienced headaches since the last revision on (b)(6) 2017.On (b)(6) 2017, the patient reported headaches, chills, and withdrawal symptoms.Interventions included a catheter evaluation on (b)(6) 2017 and again on (b)(6) 2017.The event was ongoing as of (b)(6) 2018 and resulted in an emergency room visit.Etiology indicated the event was possibly related to the device or therapy and was unlikely related to the implant procedure.The programming date from the most recent refill prior to the event was (b)(6) 2017 at 13:40.The device diagnosis was catheter occlusion.The cause of the headache/chills (patient's symptoms) was not determined.The event date was noted as (b)(6) 2017.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare provider (hcp) via a clinical study indicated the patient's baseline weight was (b)(6) pounds.It was noted that the cause of the catheter occlusion was not determined.No further complications were reported/anticipated.

Manufacturer Narrative

Product id (b)(4) serial# (b)(4) implanted: (b)(4) 2016: product type catheter: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported a catheter evaluation with no contrast was done, on (b)(4) 2017, and the catheter was unable to be aspirated.A catheter access port contrast study was performed, on (b)(4) 2017, and the catheter was able to be aspirated.

Manufacturer Narrative

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): 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: 7486907
• MDR Text Key: 107604977
• Report Number: 3004209178-2018-10107
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 11/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 07/30/2018; 08/08/2018
• Supplement Dates FDA Received: 06/04/2018; 07/30/2018; 10/04/2018
• Date Device Manufactured: 06/12/2013
• 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 Age: 58 YR
• Patient Weight: 91