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

Model Number 3788

Device Problems Nonstandard Device (1420); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Correction/removal reporting number: 1627487-12192011-003-r.This ipg serial number was included in field advisories.(b)(4).

Event Description

It was reported the patient's ipg was inoperable as the patient had not charged the ipg for several months.Surgical intervention will take place as the next course of action to address the issue.

Event Description

Follow-up identified the patient underwent surgical intervention to explant and replace the ipg.Stimulation was restored following the surgical intervention.

• 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: 5520037
• MDR Text Key: 41008755
• Report Number: 1627487-2016-01401
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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 Expiration Date: 10/28/2012
• Device Model Number: 3788
• Device Lot Number: 3218915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2010
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR