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

Model Number 8637-40

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot# n281308006, implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot #: n281308006.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via a device manufacturer representative regarding a patient receiving morphine( 50 mg/ml at 2.4 mg/day) via an implantable infusion pump.It was reported that during a pump replacement for elective replacement indicator(eri) the catheter was found to not be patent and was replaced as well.There were not any environmental/external/patient factors that may have led or contributed to the issue.The issue was reported to be resolved at the time of this report and the patient was alive with no injury.The catheter was noted to be discarded by the customer so would not be available for analysis.No further complications have been reported as a result of this event.

• 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: 7407254
• MDR Text Key: 104700894
• Report Number: 3004209178-2018-06749
• 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
• Report Date: 04/09/2018

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: 09/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/09/2018
• Date Device Manufactured: 03/30/2011
• 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: 61 YR