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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Difficult to Interrogate (1331); Pumping Stopped (1503); Unstable (1667); Human-Device Interface Problem (2949)

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

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8840, serial# unknown, product type: programmer, physician.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) on (b)(6) 2017 regarding a patient receiving unknown baclofen (2000mcg/ml at 375.5mcg/day) via an implanted infusion pump.The indications for use included intractable spasticity and multiple sclerosis.It was reported that on the date of report, the hcp was refilling the patient's pump.When the hcp attempted to interrogate the pump, the programmer stated that the hcp needed to use a magnet.The hcp reportedly put the programmer magnet on the telemetry head and reattempted interrogation, but had difficulty.The patient had lost weight and she thought the pump was flipped.The hcp then took the magnet off and reattempted with the application compatible with the patient's pump model, and was able to complete telemetry and refill the pump without difficulty.It was noted that the hcp got a motor stall message during telemetry, and it had not recovered.It had been 5 minutes since the hcp used the magnet.It was reviewed that the hcp had to have selected the incorrect pump model application to get the magnet message, and the hcp was encouraged to wait 20 minutes and then recheck the pump status with logs.It was noted that the patient had not recently undergone magnetic resonance imaging (mri).No patient symptoms were reported and 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: 6822177
• MDR Text Key: 83748186
• Report Number: 3004209178-2017-18181
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Date Device Manufactured: 03/07/2013
• 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 Age: 35 YR