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

Model Number 3788

Device Problems Pocket Stimulation (1463); Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 01/20/2014

Event Type  Injury  

Event Description

It was reported the patient experienced shocking and a pain sensation at the ipg site when stimulation is turned.The sjm representative met with the patient and lead diagnostics showed all contacts had low impedances.X-rays were taken and indicated the scs system is intact with no visible issues.The patient is doing well with pain relief without using the scs system.In addition, the patient is needing an mri therefore the patient's entire scs system will be removed.Surgical intervention is pending to address the issue.

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 MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3667221
• MDR Text Key: 4202053
• Report Number: 1627487-2014-26105
• 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
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2013
• Device Model Number: 3788
• Device Lot Number: 3536386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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: SCS EXTENSION: MODEL 3383 (2); SCS LEAD: MODEL 3183 (2); IMPLANT:; IMPLANT:; SCS ANCHOR: MODEL 1194 (2); IMPLANT:
• Patient Outcome(s): Other
• Patient Age: 16 YR