MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 863740

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591); Application Program Problem (2880); Inappropriate or Unexpected Reset (2959)

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

Event Type  malfunction  

Manufacturer Narrative

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 professional (hcp) regarding a patient who was receiving 100mcg/ml baclofen at 0.6mcg/day via an implantable infusion pump for intractable spasticity and other spasticity.It was reportedthat an alarm occurred for end of service (eos).No symptoms were reported.No further complications were anticipated /reported.***** omitted information 500176565 scar tissue, medication overload****additional information was received from the consumer that reported that the pump was running but was starting to ¿die out¿.Per the patient for a couple of years the patient could hear the alarm every 20 minutes and on (b)(6) 2017 could hear the alarm every 30 seconds.The patient was taking oral medication now and wanted to get the pump removed since it was not helping.The patient also reported that they were dizzy and needed to lay down and stated it was not due to the pump.It was noted the patient did not have a healthcare provider and was sent physician listings.No further patient complications were reported.Additional information was received from a healthcare professional.A healthcare professional reported that they had only seen the patient in their office.The hcp had been asked to shut off the baclofen pump.The hcp was not involved in placing or filling the pump.The pump had been off for several years and had been alarming more recently.The hcp called the manufacturer who walked the hcp through the process of shutting off the alarm.The hcp has no further information regarding the issue.The patient did suggest they would like to have the pump explanted at some pump.The last interrogation of the pump was done on (b)(6) 2017 and the last refill was done on (b)(6) 2013.The pump logs showed that the pump had an elective replacement indicator message as well as a stopped pump period may exceed tube set message, end of service message, pump reset message, and terminal event occurred message.The schedule to replace by date for the elective replacement indicator was (b)(6) 2090.No further complications were anticipated/reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6904419
• MDR Text Key: 89501112
• Report Number: 3007566237-2017-04124
• 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: Physician
• Type of Report: Initial
• Report Date: 09/29/2017

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: 08/14/2007
• Device Model Number: 863740
• Device Catalogue Number: 863740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/29/2017
• Date Device Manufactured: 02/24/2006
• 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