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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)

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

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot # :(b)(4) ubd: (b)(6) 2016, 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 baclofen (100 mcg/ml, 39.97 mcg/ml), dilaudid (15.0 mg/ml, 5.995 mg/day) and bupivacaine (7.5 mg/ml, 2.9975 mg/day) via an implantable infusion pump for the treatment of non-malignant pain and chronic low back pain.It was reported that the hcp was unable to aspirate catheter due to clogged catheter.They tried to trim catheter to clear blockage and the catheter was replaced with a new 8780 catheter.There was no environmental/external/patient factors that may have led or contributed to the issue.The issue was resolved and patient status was alive with no injury at the time of the report.No further complication was 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: 7568765
• MDR Text Key: 110052921
• Report Number: 3004209178-2018-12566
• 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: 06/05/2018

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: 11/28/2012
• 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: 06/04/2018
• Initial Date FDA Received: 06/05/2018
• Date Device Manufactured: 06/03/2011
• 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: 47 YR