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

Model Number 3788

Device Problems No Device Output (1435); Moisture or Humidity Problem (2986)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/28/2014

Event Type  Injury  

Event Description

It was reported the patient had not charged her ipg in approximately 1 month and is without stimulation.The sjm representative met with the patient and was unable to locate the ipg via the charger.Additionally, the programmer displayed a communication error message.X-rays are to be taken and surgical intervention may take place at a later date.

Manufacturer Narrative

Recall: 1627487-07262012-002-r, 1627487-12192011-003-r.This ipg serial number was included in field advisories.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.See scanned page.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 4383526
• MDR Text Key: 5291980
• Report Number: 1627487-2014-15822
• 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: Recall
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2010
• Device Model Number: 3788
• Device Lot Number: 172202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Treatment: IMPLANT:; IMPLANT:; SCS LEAD: MODEL 3186 (2); SCS ANCHOR: MODEL 1194 (2)
• Patient Outcome(s): Other
• Patient Age: 49 YR