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

Model Number 3788

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Removal/reporting: 1627487-07262012-001-c.This ipg serial number was included in a field advisory and a field correction.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.

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2015-26653.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The date of explant is unknown.

Event Description

Additional information revealed that the patient underwent surgical intervention approximately two years ago (exact date unknown) wherein the ipg was explanted and replaced with a competitor ipg.The leads remain implanted.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 5258672
• MDR Text Key: 32435855
• Report Number: 1627487-2015-26654
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

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: Health Professional
• Device Expiration Date: 07/28/2013
• Device Model Number: 3788
• Device Lot Number: 3434520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/27/2019
• Date Device Manufactured: 07/06/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: MODEL 1192 M(2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 32 YR