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 Problems Respiratory Distress (2045); Dysphasia (2195); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8596, serial# (b)(4), implanted: (b)(6) 2007, product type: catheter.Product id: 8709, serial# (b)(4), implanted: (b)(6) 2007, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was receiving gablofen, unknown concentration at unknown dose via intrathecal drug delivery pump for intractable spasticity and head/brain injury.It was reported that patient was admitted to hospital for respiratory issues.When they were discharged it was suggested that a catheter access port procedure be performed to ensure the catheter was working properly and to confirm expected vs actual during a refill as well.At the time of this report, the issue had not resolved and patient status was alive-no injury.No further complications were reported.Additional information was received from a healthcare professional via manufacturer representative (rep).It was reported that a hcp initially reported the event to the rep.The cause of respiratory issues was that the patient was very sick and was non verbal.The patient blinked for yes or no.The rep could not determined.The patient may just be sick.The rep read the pump and no alarms came up.The rep was unsure if the issue had resolved.The patient may be admitted for a while for non therapy issues.No further complications were reported.

• 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: 8689211
• MDR Text Key: 147716663
• Report Number: 3004209178-2019-11382
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• 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: 06/03/2019
• Date Device Manufactured: 09/03/2013
• 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