MAUDE Adverse Event Report: RICE CREEK MFG SYNCHROMED EL; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8627L18

Device Problems Electromagnetic Interference (1194); Difficult to Interrogate (1331); Pumping Stopped (1503); Data Problem (3196)

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

Event Date 12/16/2013

Event Type  malfunction  

Event Description

A pump memory error was reported.The error occurred during interrogation.They went to test the alarm and found it difficult to do telemetry; they then found the pump was in stopped mode and a pump memory error occurred.This happened after telemetry.They got another 8840, interrogated again and successfully updated the pump.This resolved the reported issue.Per the reporter they are weaning the patient down and likely not replacing pump when it reaches eos.The pump was used to deliver baclofen.Additional information later reported there may have been emi from the bedside medical equipment but nothing definite.The patient was at baseline.No troubleshooting was done.

Manufacturer Narrative

Concomitant products: product id 8709, serial # (b)(4), implanted: (b)(6) 2004, product type catheter; product id 8840, serial # unknown, product type programmer, physician.(b)(4).

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: chad hedlund ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149619
• MDR Report Key: 3551006
• MDR Text Key: 18363526
• Report Number: 6000030-2014-00003
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2005
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2013
• 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: 00045 YR