MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION EONC; SCS IPG

Model Number 3688

Device Problems Device Remains Activated (1525); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Discomfort (2330)

Event Date 05/23/2014

Event Type  Injury  

Event Description

Device 1 of 3.Ref mfr reports: 1627487-2014-03422 and 1627487-2014-03423.The pt's spouse reported the pt stopped using his scs system due to painful and ineffective stimulation.It was also reported the pt was to undergo a trial procedure to address the issue; however, the scs ipg turned itself back on.The pt attempted to turn the system off using a magnet to no avail.Additionally, it was reported the pt was unable to establish communication between his scs ipg and pt programmer (received 2501 comm error) which resulted in the inability to turn off the system.Subsequently, the pt was taken to the er and the scs ipg was explanted.

Manufacturer Narrative

Sjm has limited info related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: EONC
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 3916316
• MDR Text Key: 4519322
• Report Number: 1627487-2014-03421
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2010
• Device Model Number: 3688
• Device Lot Number: 176446
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2008
• 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 Outcome(s): Other
• Patient Age: 63 YR