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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Pumping Stopped (1503)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional via manufacturer representative (rep) regarding a patient who was receiving baclofen (unknown) at an unknown concentration and dose via intrathecal drug delivery pump for intractable spasticity and cerebral palsy.It was reported that a motor stall was seen at initial interrogation and it was unknown if the patient recently had an mri (magnetic resonance imaging).Pump status and/or event log reported "motor stall occurred; motor stall (active)." the pump was being replaced "today." a dye study was done "yesterday" to check the catheter and it "looked okay." withdrawal was reported with no specific symptoms.It was unknown when the event occurred.The rep inquired about how to get a return mailer kit to send the pump back.No further complications were reported.

Manufacturer Narrative

Other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional.It was reported that the catheter appeared to have been occluded but they were not sure if that was cause of the motor stall.The motor stall and withdrawal were resolved by replacement of the pump.No further complications were reported.

• 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: 7171660
• MDR Text Key: 96613721
• Report Number: 3004209178-2018-00368
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: 01/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/10/2018
• Date Device Manufactured: 08/07/2012
• 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-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 9