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

Model Number 8637-40

Device Problems Suction Problem (2170); Human-Device Interface Problem (2949); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8784, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2018, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 11-oct-2014, 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 (hcp) via a device manufacturer representative regarding a patient receiving dilaudid(2 mg/ml at.2 mg/day) via an implantable infusion pump.It was reported that the healthcare provider (hcp) attempted to aspirate through the side port and the catheter would not aspirate.The catheter was trimmed 5cm from the pump connector and was replaced with a new connector and pump segment.There were no environmental/external/patient factors that may have led or contributed to the issue.No symptoms were reported.The issue was resolved and the patient was alive with no injury.It was reported that the catheter would be returned for analysis.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.The main component of the system, other relevant device(s) are : product id: 8780, serial# (b)(4), ubd 2014-10-19, udi# (b)(4).Analysis of the 8784 catheter revealed catheter broken; catheter body; damage to the transition tube.Analysis of the 8780 catheter revealed catheter body; kinked observed.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: 7747549
• MDR Text Key: 115942554
• Report Number: 3004209178-2018-17375
• Device Sequence Number: 1
• Product Code: LKK
• 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,Followup,Followup
• Report Date: 10/30/2018

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: 04/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/29/2018
• Supplement Dates FDA Received: 10/03/2018; 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• 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): Required Intervention
• Patient Age: 34 YR