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

Model Number 8637-20

Device Problems Kinked (1339); Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Aspiration Issue (2883)

Patient Problem Pain (1994)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Other relevant components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: catheter.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 clinical study and a manufacturer representative (rep) regarding a patient receiving fentanyl 1000mcg/ml for a total dose of 132mcg/day and bupivacaine 0.6mg/ml for a total dose of 0.07921mg/day via an implantable pump for non-malignant pain and cervical/neck.It was reported the patient had a catheter occlusion and had increased pain over the summer time.A catheter dye study was done in (b)(6), and the dye study failed as they were unable to aspirate.The hcp reported a catheter access port study was performed on (b)(6) 2017 and revealed catheter migration.This conflicts with the information provided from the rep.During surgery, the hcp was unable to aspirate the catheter and noted that the catheter had a kink distal to the anchor.It was noted that the cause of the increased pain was due to the occluded catheter.It was noted that the catheter occlusion and increased pain had been resolved without sequelae on (b)(6) 2017.The entire system was explanted/replaced on (b)(6) 2017.It was noted that the catheter will be returned for analysis and the pump was replaced to a 40cc pump and the old pump was disposed of.It was later reported via hcp that over the past several months the patient's pain had been poorly controlled.Evaluation in the pain clinic revealed downward migration of the patient's intrathecal catheter in the spinal canal to c5 level.The catheter original location was c1.The clinical diagnosis was poorly controlled pain and the device diagnosis was catheter dislodgement.The etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was not possibly related.The event date was 2017.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider via a clinical study reported the cause of the catheter occlusion, kink, and migration/dislodgement was not determined.The patient's baseline weight was (b)(6).

Manufacturer Narrative

Analysis of the catheter identified a compressed area in the catheter body.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: 7157787
• MDR Text Key: 96171417
• Report Number: 3004209178-2018-00067
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2014
• 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: 49 YR
• Patient Weight: 68