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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG Back to Search Results
Model Number 3788
Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)
Patient Problems Erythema (1840); Discomfort (2330); Inadequate Pain Relief (2388)
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 has been experiencing heating, discomfort, redness, tenderness, and soreness at the ipg site whether stimulation is on or off. It was also reported the patient's ipg has been turning on and off by itself. Troubleshooting was unable to provide resolution. The patient will undergo surgical intervention on a later date.
 
Event Description
Follow-up revealed the patient's ipg was explanted and replaced. The doctor also relocated the patient's ipg site. Surgical intervention resolved the patient's issue.
 
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Brand NameEON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of DeviceSCS 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 Key5663873
MDR Text Key45419855
Report Number1627487-2016-02559
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2015
Device Model Number3788
Device Lot Number4256317
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/18/2016 Patient Sequence Number: 1
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