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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
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 05/29/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported the ipg was inoperable due to not charging.As a result, the ipg was replaced and therapy was restored post-op.
 
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Brand Name
EON MINI IPG, 16-CHANNEL RECHARGEABLE
Common Device Name
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key7638434
Report Number1627487-2018-06053
Device Sequence Number16747181
Product Code LGW
UDI-Device Identifier05414734402620
UDI-Public05414734402620
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/26/2018
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
Operator of Device Health Professional
Device Expiration Date10/28/2012
Device Model Number3788
Device Lot Number3234925
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 05/29/2018
Initial Report FDA Received Date06/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MODEL 3163, SCS LEAD; MODEL 3244, SCS LEAD
Outcome Attributed to Adverse Event Other;
Patient Weight63
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