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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 Problem Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/20/2018
Event Type  Injury  
Manufacturer Narrative
Continued: this ipg serial number was included in multiple field advisories. 1627487-07262012-002-r, 1627487-12192011-003-r. The manufacturer 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. The manufacturer defers to the patient's physician regarding medical history.
 
Event Description
It was reported the patient's scs charging system was unable to communicate with their ipg. Reportedly, troubleshooting the issue as well as replacing the charger was unsuccessful. In turn, the patient programmer displayed an error message deeming the device inoperable. As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced with an updated model. Effective therapy was established and the issue resolved.
 
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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 Key7524755
MDR Text Key108600163
Report Number1627487-2018-04713
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 company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2011
Device Model Number3788
Device Lot Number2772041
Other Device ID Number05414734402651
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 Received04/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-05242011-002-R

Patient Treatment Data
Date Received: 05/17/2018 Patient Sequence Number: 1
Treatment
MODEL 3219, SCS LEAD
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