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

Model Number 3716

Device Problems Inadequacy of Device Shape and/or Size (1583); Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 10/24/2007

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-15740.It was reported the patient has experienced uncomfortable heating at the ipg site while charging since implant.A replacement charging system was sent to the patient, however the issue persisted.Additionally, the patient experiences discomfort at the ipg site due to the size and location of the ipg.Surgical intervention may take place at a later date.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.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 advisory and 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.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-15740.Follow-up information indicated surgical intervention was undertaken and the patient's ipg was explanted and replaced.

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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDCIAL - NEUROMODULATION; plano TX
• Manufacturer Contact: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 4169560
• MDR Text Key: 5022364
• Report Number: 1627487-2014-15739
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2009
• Device Model Number: 3716
• Device Lot Number: 69756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2007
• 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: SCS LEAD: MODEL 3228; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 39 YR