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

Model Number 863740

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

Update - the following also applies: z-2276-2009.

Manufacturer Narrative

(b)(4).

Event Description

Information was received from a healthcare provider via a company representative regarding a patient who was receiving fentanyl with concentration 50 mcg/ml at a dose rate of 47.964 mcg/day, baclofen of unknown concentration and unknown dose rate, and marcaine of unknown concentration and unknown dose rate via an implantable pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient chose not to have their pump refilled 4 years ago and then the pump started alarming.The date of the event was 2012.The pump has not been delivering drug for the past 4 years.The patient let the pump continue to run and the empty reservoir alarm occurred 4 years ago and now it has reached end of service (eos).The pump alarm heard was confirmed via telemetry.A critical alarm was occurring regarding a motor stall, eos, and low battery reset.All the event logs had "??" for the dates so it could not be determined when the alarms actually occurred.No patient symptoms were reported.The following additional information has been requested which was not available at the time of the report: clarification of why the patient chose not to refill the pump, if there was a device/therapy issue, and what actions were taken to resolve the empty pump reservoir and alarms.If additional information is received, a follow-up report will be submitted.

• 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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5489168
• MDR Text Key: 40178100
• Report Number: 3007566237-2016-01327
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2007
• Device Model Number: 863740
• Device Catalogue Number: 863740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Date Device Manufactured: 01/25/2006
• 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