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); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 18-oct-2012, 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 company representative regarding a patient receiving dilaudid 20mg/ml at 1.5mg/day and baclofen 750mcg/ml at 56mcg/day via implantable pump.The indications for use were spinal pain and failed back surgery syndrome.It was reported that the patient was scheduled for a pump replacement on (b)(6) 2018.The pump was 3 months until eri (elective replacement indicator).The patient did not experience any symptoms prior to the pump replacement.The catheter was occluded at the time of the pump replacement.There were no known environmental, external or patient factors that may have led or contributed to the issue.The physician tried to aspirate from the cap (catheter access port) of the old pump, directly from the catheter, and also replaced the 8578 sutureless connector and could still not successfully aspirate the catheter.It was unknown where the occlusion was.The physician did not use any imaging for a dye study.The physician was unable to aspirate the catheter and get csf (cerebral spinal fluid) flow so a back table prime was performed before the catheter was connected to the new pump.The physician wanted to do a back table prime and replace the connector instead of replacing the entire catheter.The issue was resolved at the time of the report.The patient status was noted as alive, no injury and 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: 7433267
• MDR Text Key: 105884755
• Report Number: 3004209178-2018-08120
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• 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: 04/16/2018
• Date Device Manufactured: 09/23/2011
• 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 Age: 64 YR