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

Model Number 3716

Device Problems Unit inactivated (1662); Use of Device Problem (1670); Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 04/20/2012

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report#: 1627487-2014-25129, 25130.It was reported the patient has not charged in several months.As a result, the ipg is operable.It was also reported the patient experienced heating and overstimulation.On 08/01/2012, st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.As 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 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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3683327
• MDR Text Key: 4292572
• Report Number: 1627487-2014-25128
• 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: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2012
• Device Model Number: 3716
• Device Lot Number: 3224692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• 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
• Patient Outcome(s): Other
• Patient Age: 32 YR