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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2018-june-19, information was received from a healthcare professional (hcp) regarding a patient receiving gablofen (500 mcg/ml, flex dose 107.2 mcg/day) via an implantable pump for intractable spasticity and multiple sclerosis.The hcp called to report two volume discrepancies of actual reservoir volume (arv) greater than expected reservoir volume (erv).The first volume discrepancy was identified on (b)(6) 2017; arv=25cc erv=5cc.The second discrepancy was identified on (b)(6) 2018-jun-19; arv=34cc erv=2.2cc.Event logs were checked and were normal except for a motor stall occurring on (b)(6) 2017 at 0858 with a motor stall recovery occurred on the same date at 0944.The hcp confirmed that the patient had an magnetic resonance imaging (mri) on the date of the motor stalls.The hcp stated they had an order for a catheter dye study and that they did not feel comfortable programming a single bolus dose safe for the patient to confirm patient response.No patient symptoms reported.No further information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial #: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial #: (b)(4), ubd: 2016-jan-08, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) and consumer via a company representative.The patient¿s medical history included multiple sclerosis.It was reported that the patient stated that their catheter was not working.The patient experienced a return of symptoms on an unknown date.Surgical intervention occurred.During the procedure they were unable to aspirate via the catheter access port (cap).It appeared that the catheter was kinked at the anchor site.The entire catheter and pump were replaced.Environmental/external/patient factors that may have led or contributed to the issue was indicated as being unknown.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.The pump administered baclofen with concentration 500 mcg/ml at a dose rate of 70 mcg/day.The drug lot number of baclofen was unable to be obtained.Other medications (oral, etc.) the patient was receiving at the time of the event was unable to be obtained.The patient¿s weight was provided.

Manufacturer Narrative

The previously reported device code (b)(4) no longer applies to this event and has been updated to (b)(4) and (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.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-july-12, additional information was received from the healthcare professional (hcp).Additional information stated that they were not able to complete the dye study because the catheter was not functional.The cause of the volume discrepancies was "catheter failure".The patient was scheduled for a catheter revision in (b)(6) 2018.

• 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
• MDR Report Key: 7622051
• MDR Text Key: 111990094
• Report Number: 3004209178-2018-13930
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 70