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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was provided by a consumer (friend/family member) regarding an implantable intrathecal pump intended to deliver an unknown type of baclofen (concentration and dose unknown). The caller stated that he wanted to say "2000 mikes," but he was not sure. The indications for use were intractable spasticity and multiple sclerosis. It was reported that the patient went to see her managing healthcare provider (hcp) on (b)(6) 2018 for a refill and they told her she had a motor malfunction. The event date was unknown. It was stated that the patient did not get the long strip and does not know the date that the issue occurred. However, it was sometime between her last refill and yesterday. It was reported that the message was ¿motor malfunction¿ and tube set; this occurred sometime after her previous refill which was 4-5 months ago, in 2017. It was noted that the patient¿s hcp had asked the patient if she had an mri (magnetic resonance imaging), to which the patient stated that she had. The mri was not due to the device or therapy. It was stated that the patient routinely gets mris, and that the mri was probably a brain scan to see if the myolin from the patient's multiple sclerosis (ms) has progressed. Patient services (ps) reviewed mri pump information, and the caller stated that this was the first anyone ever told them this. A patient manual was offered and sent via email. The patient was to continue working with her hcp. No patient symptoms were reported.

Manufacturer Narrative

Patient weight is an estimate, as it was reported that the patient's weight at the time of the event was between (b)(4) pounds. Device codes (b)(4) and conclusion code (b)(4) no longer apply. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider on (b)(6) 2018. It was reported that a motor stall recovery was noted in the logs. It was confirmed that the date of the motor stall in the logs corresponded with a date that the patient had an mri. It was reported that patient did not recall experiencing any symptoms related to the motor stall. It was reported that as an action/intervention to resolve the motor stall, the pump was restarted and refilled. It was noted that during the refill, the volume did not deviate greatly from expected. It was reported that the patient's weight at the time of the event was between 130 and 150 pounds. No further complications 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: 7327635
• MDR Text Key: 102086630
• Report Number: 3004209178-2018-04765
• 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: consumer,health professional

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0591-2009