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

Model Number 8637-40

Device Problems Kinked (1339); Migration or Expulsion of Device (1395); Volume Accuracy Problem (1675); Aspiration Issue (2883)

Patient Problems Muscle Spasm(s) (1966); Muscle Weakness (1967)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, 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-nov-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a healthcare provider(hcp) via a manufacturer regarding an implantable intrathecal pump intended to del iver gablofen [500 mcg/ml] at 250 mcg/day, indicated for intractable spasticity and stroke.On (b)(6) 2018, it was reported that the patient had been complaining of slowly increasing spasticity for approximately the last three months.The event date was asked but would not be made available due to a legal/confidential reason.The hcp did a side-port aspiration on (b)(6) 2018 was negative, they were unable to draw back any fluid.It was also noted that on the last refill, the expected reservoir volume (erv) was 3.6 ml and the actual reservoir volume was 9 cc, so the hcp is thinking there is some sort of kink in the catheter not allowing for full flow.It was noted that all other expected versus actual at the time of refill had been normal.It was indicated that there were no environmental, external, or patient factors that may have led or contributed to the issue.As an action/intervention, the patient was scheduled for a catheter revision on (b)(6) 2018.The issue was not resolved at the time of the report.Surgical intervention was scheduled but had not yet occurred.The patient's status at the time of the report was listed as ¿alive ¿ no injury.¿ the patient¿s medical history and weight were asked but would not be made available due to a legal/confidential reason.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.Additional information was received on (b)(6) 2018.It was reported that the patient was taken to the operating room (or) for exploration and revision of the catheter.The surgeon also decided to replace the pump since it was implanted in 2012.It was reported that the catheter was found to be pulled out of the intrathecal space and was in the subcutaneous tissue.It was indicated that it was unsure how or when this happened.The v-wing anchor was still attached to the fascia.The patient reported never experiencing withdrawal symptoms.Per the patient, they experienced fluctuating tone over the last few months, but no withdrawal.The old pump and catheter were both completely removed and replaced.The new pump was filled with lioresal [500 mcg/ml] and restarted at a dose of 100 mcg/day, per the managing hcp.It was noted that the hospital has possession of the explanted products.They were asked to return to the manufacturer for analysis, but the hospital¿s policy is that the devices go to gross, so it was unknown if they would be returned.It was noted that the patient had a follow-up appointment with their managing physician scheduled for (b)(6) 2018.No further co mplications were reported or anticipated.

• 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: 7646348
• MDR Text Key: 112623144
• Report Number: 3004209178-2018-14570
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Date Device Manufactured: 05/29/2012
• 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