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); Volume Accuracy Problem (1675); Aspiration Issue (2883)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving compounded baclofen, 2000 mcg/ml concentration at 1200 mcg/day dose via intrathecal drug delivery pump for intractable spasticity and other spasticity.It was reported that lack of therapy despite increases in dosages, as well as residual volumes higher than expected at refill occurred.Any environmental/external/patient factors were unknown.Dye study was attempted on 3/27, but was unable to aspirate catheter.The hcp was unable to determine exact cause of sluggish cerebrospinal fluid (csf) flow through the catheter during interoperative troubleshooting.The hcp replaced the catheter after attempts to troubleshoot and diagnose the existing catheter's lack of patency failed to identify the exact issue.The hcp did find a significant amount of tissue that had accumulated in the sutureless connector portion of the catheter.The hcp also replaced the pump prophylactically as it was nearly 5 years old.The pump segment of the catheter, the pump, and the tissue removed from sutureless connector would be returned to the manufacturer for analysis on the sutureless connector/pump connection.At the time of this report, the issue was resolved and patient status was alive-no injury.No further complications were reported.

Manufacturer Narrative

The pump and catheter were returned, and analysis found pump/miscellaneous/overinfusion- undetermined root cause and catheter/catheter body/damage to transition tube.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: 7413133
• MDR Text Key: 104920552
• Report Number: 3004209178-2018-06930
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2013
• 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: 51 YR