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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problem Underdose (2542)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving an unknown intrathecal medication via an implanted pump for non-malignant pain.Compatibility guidelines were requested for mri.It was unknown if the procedure was due to a problem with the device or therapy.The mri technician reported they thought she understood that the patient said they have not been receiving drugs and the pump was stalled.The hcp was trying to wean the patient off of the drugs to replace the pump with a stimulation device.The event date was asked and unknown.Additional information was received from the manufacturer's representative (rep) on (b)(6) 2018.The drugs being delivered were 4,40 0 mcg/ml fentanyl, 16 mg/ml hydromorphone, and 24 mg/ml bupivacaine, all at minimum rate dosages.It was reported that there was an empty pump.The caller does have access to the pt/8840.The reason for the call was that they were with the patient checking their pump post-mri and they were not seeing a motor stall or a motor stall recovery message.The caller stated that the pump was currently in minimum rate.It was reviewed that it is possible for the pump not to detect a motor stall due to the low flow rate.The caller stated that the pump was put in minimum rate on (b)(6) 2018 when that patient went in to the healthcare professional (hcp) due to not having medication in the pump.The event date was reported as 2017, ¿sometime during the holidays last year.¿ they put the pump in minimum rate and are weaning the patient off so they can explant the pump.It was confirmed that ¿there are no issues with the pump, the patient just no longer wants the pump anymore.¿ there were no symptoms reported.There were no further complications reported/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: 7296248
• MDR Text Key: 101172843
• Report Number: 3004209178-2018-03940
• 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,consum
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Date Device Manufactured: 10/29/2012
• 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 Age: 62 YR