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

Model Number 8637-40

Device Problem Application Program Problem (2880)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/05/2014

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), product type: catheter.(b)(4).

Event Description

It was reported that the patient had a mri on (b)(6) 2014 and returned to the clinic the next day to check the status of the pump.The pump event logs were checked, and there was no motor stall log or motor stall recovery log found.The patient had complained of decreased efficacy since the mri was performed.It was later reported that the mri was of the lumbar spine which lasted about 25 minutes.The patient noted increased pain over the night.Upon further interview, the patient had nausea and sweats for two weeks or more.When the pump was interrogated, it did not give the prompt that the pump had been stopped.The event logs were read; the latest entry in the logs was (b)(6) 2014, which was the last time the patient's pump was refilled.The rate said "simple continuous," and the health care provider was able to reprogram the pump with a 0% change without an apparent event.The patient was discharged home with oral pain medications with the plan to interrogate the pump the following day.A week after the mri the patient reported to the health care provider that the pump was working fine.The pump was to be read on (b)(6) 2014.The drugs in the pump were marcaine and dilaudid.

• 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): 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: 4936519
• MDR Text Key: 24647385
• Report Number: 3004209178-2015-14019
• 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: Health Professional
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2011
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Date Device Manufactured: 02/17/2010
• 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: 00054 YR