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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 05/11/2018
Event Type  Injury  
Manufacturer Narrative
Recall number: 1627487-12192011-003-r.This ipg serial number was included in multiple field advisories.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 lost stimulation sometime in (b)(6) 2018.Reportedly, the ipg will no longer communicate with any external devices and was subsequently deemed inoperable.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced which resolved the issue.
 
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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 Key7584478
MDR Text Key110570426
Report Number1627487-2018-05036
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 Physician
Remedial Action Recall
Type of Report Initial
Report Date 06/08/2018
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? Yes
Device Operator Health Professional
Device Expiration Date04/28/2012
Device Model Number3788
Device Lot Number3103970
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2018
Initial Date FDA Received06/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-07262012-002-R
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
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