MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problems Failure to Charge (1085); No Device Output (1435); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It was reported the patient did not charge her ipg for approximately 6 months.As a result, the patient's ipg became inoperable.Subsequently, the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced.This report was originally submitted on (b)(6) 2015 under mfr report # 1627487-2015-260155.The filing is hereby resubmitted to reflect the appropriate mfr report number.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 5137322
• MDR Text Key: 27817817
• Report Number: 1627487-2015-23085
• 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: Other
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/28/2015
• Device Model Number: 3788
• Device Lot Number: 4179927
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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: MODEL 3228, SCS LEAD, IMPLANT DATE
• Patient Outcome(s): Other
• Patient Age: 39 YR