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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Volume Accuracy Problem (1675)

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

Event Date 01/01/2018

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) via a device manufacturer representative regarding a patient who was receiving an unknown drug via an implantable infusion pump.It was reported that the patient had an mri in (b)(6) 2018 and they did not have the pumped checked after.A motor stall was seen at initial interrogation.Pump status showed that a motor stall and the stopped pump period may exceed tube set message occurred.The hcp refilled the pump on (b)(6) 2018 and the expected versus actual volumes were very close.The patient experienced no withdrawal symptoms and they did not report hearing audible alarms.The patient was already gone by the time the device manufacturer representative received information from the hcp, so they had no opportunity to check the logs on (b)(6) 2018.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the motor stall message correlated with when the patient had her mri, per the healthcare provider (hcp).No further actions had been taken at the time of the report.The issue was resolved at the time of the report.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 MN 00777 1200
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7446555
• MDR Text Key: 106629839
• Report Number: 3007566237-2018-01168
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• 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: 04/17/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 05/15/2018
• Date Device Manufactured: 01/16/2012
• 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: 79 YR