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); Obstruction of Flow (2423); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problems Muscular Rigidity (1968); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter; product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4); 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 health care provider (hcp) via a device manufacturer representative regarding a patient receiving gablofen (2000 mcg/ml at 941 mcg/day) via an implantable infusion pump.The indication for use was noted to be intractable spasticity due to cerebral palsy.It was reported that the patient had reported an increase in spasticity on an unknown date.A dye study was inconclusive and the pump logs were normal.The patient was scheduled for surgery to move the pump to a more comfortable location in the right abdomen and during the surgery the catheter was found to not be patent.There was no cerebrospinal fluid flow seen and they could not aspirate the catheter.The whole catheter was replaced.They would be returned for analysis.There were no known environmental, external or patient factors which may have led or contributed to the issue.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable intrathecal catheter (s/n (b)(4) found a compressed area in the catheter body and a kink in the catheter body.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7545036
• MDR Text Key: 109274107
• Report Number: 3004209178-2018-11893
• 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,Followup
• Report Date: 10/04/2018

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: 05/28/2014
• 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: 05/24/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 08/08/2018
• Supplement Dates FDA Received: 08/08/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2012
• 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 Weight: 54