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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 Stops Intermittently (1599)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported the patient (b)(6) experienced their ipg shut off by itself. In turn, their scs system was explanted. Also, the patient's extension was electively explanted on the same day as the patient's ipg. The patient's lead was explanted on (b)(6)2017 and reported under mfr. Report# 1627487-2017-03177. Note: their ipg was also reported as explanted under mfr. Report# 1627487-2017-03179.
 
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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 Key6645434
MDR Text Key77702395
Report Number1627487-2017-03214
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2015
Device Model Number3788
Device Lot Number4136482
Other Device ID Number05414734402651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2013
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: 06/15/2017 Patient Sequence Number: 1
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