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

Model Number 3716

Device Problems Disconnection (1171); Device Stops Intermittently (1599)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/12/2014

Event Type  Injury  

Event Description

Device 5 of 5.Reference mfr report: 1627487-2014-02732, 02733, 02734, 02735.

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 MED - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 4253004
• MDR Text Key: 5016062
• Report Number: 1627487-2014-02799
• 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: 10/21/2014

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?: Yes
• Device Operator: Other
• Device Expiration Date: 09/01/2012
• Device Model Number: 3716
• Device Lot Number: 3199471
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS ANCHOR: MODEL 1192 (X2); IMPLANT DATE:; SCS EXTENSION: MODEL 3343 (X2)
• Patient Outcome(s): Other
• Patient Age: 63 YR