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

Model Number 3788

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Twiddlers Syndrome (2114)

Event Date 01/28/2014

Event Type  Injury  

Event Description

It was reported the pt has been picking at her ipg site and is pulling the wires.Surgical intervention is pending to address this issue.

Manufacturer Narrative

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 MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3683386
• MDR Text Key: 4294137
• Report Number: 1627487-2014-26129
• 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: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3788
• Device Lot Number: 3734243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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:; SCS ANCHOR: MODEL 1192 (2); IMPLANT DATE:; SCS LEAD: MODEL 3186 (2); SCS EXTENSION: MODEL 3386 (2); IMPLANT DATE:
• Patient Age: 65 YR