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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG Back to Search Results
Model Number 3688
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 11/26/2019
Type of Reportable Event Serious Injury
Additional 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.During processing of this complaint, attempts were made to obtain patient information.Further information was requested but not received.Date of event is estimated.
 
Event or Problem Description
It was reported the patient lost therapy due to the ipg becoming inoperable.In turn, the ipg was explanted and replaced to address the issue.
 
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Brand Name
EON C 16-CHANNEL IPG
Common Device Name
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key9440422
Report Number1627487-2019-13727
Device Sequence Number3987734
Product Code LGW
UDI-Device Identifier05415067017369
UDI-Public05415067017369
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/09/2019
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
Operator of Device Health Professional
Device Expiration Date07/31/2017
Device Model Number3688
Device Lot Number5167832
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2019
Initial Report FDA Received Date12/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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