MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON PT PROGRAMMER; SCS PT PROGRAMMER

Model Number 3851

Device Problem Sticking (1597)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

It was reported the pt experienced overstimulation from her scs system upon establishing communication with her ipg and pt programmer.The pt stated she attempted to adjust her stimulation level, but the stimulation ramped up all the way.The pt stated she was able to adjust the stimulation down by holding the decrease (-) button on her pt programmer and moving the antenna (paddle) away once she reached the desired level.The issue could not be duplicated by sjm technical services while on the phone with the pt.Technical services suspected an intermittent stuck increase (+) button on the pt programmer.Furthermore, the pt underwent surgical intervention due to discomfort (ref.Medwatch report: 1627487-2014-03388) at her scs ipg site on (b)(6) 2014.The pt's ipg was replaced with a different model ipg and the pt received a new pt programmer.Follow up on (b)(6) 2014 identified the reported issue resolved with the new programmer.

Manufacturer Narrative

Sjm has limited information 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: EON PT PROGRAMMER
• Type of Device: SCS PT PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3998787
• MDR Text Key: 15813351
• Report Number: 1627487-2014-02404
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 3851
• Device Lot Number: 4291861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: IMPLANT DATE:; IMPLANT DATE:; IMPLANT DATE:; SCS IPG, MODEL 3788; SCS LEAD, MODEL 3186 (X2); SCS ANCHOR, MODEL 1192 (X2)
• Patient Age: 53 YR