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

Model Number 3716

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Temperature Problem (3022)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146)

Event Date 07/01/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-15565.It was reported the pt alleges she experiences overstimulation, as well as pain and heating at the ipg site while charging.Also, the pt indicated reprogramming attempts were undertaken to no avail.The pt desires to have her scs explanted.Surgical intervention may be taken at a later date.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to pts related to heating while charging and raised awareness of this issue to pts.An increase in prior non-reported heating while charging events and other non-reported events was expected.

Manufacturer Narrative

This ipg serial number was included in a field correction.Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: EON
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 3979910
• MDR Text Key: 21241399
• Report Number: 1627487-2014-15564
• 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: Other
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: 3716
• Device Lot Number: 3439304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Treatment: IMPLANTED:; SCS LEAD: MODEL 3228
• Patient Outcome(s): Other
• Patient Age: 56 YR