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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL; SCS IPG Back to Search Results
Model Number 3716
Device Problems Device Stops Intermittently (1599); Low impedance (2285); Impedance Problem (2950)
Patient Problem Inadequate Pain Relief (2388)
Event Date 02/10/2015
Event Type  Injury  
Event Description
Device 1 of 2.Reference mfr.Report# 1627487-2015-20145.
 
Event Description
Device 1 of 2.Reference mfr.Report# 1627487-2015-20145.
 
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.
 
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
Device 1 of 2.Reference mfr.Report# 1627487-2015-20145.It was reported the patient experienced intermittent stimulation.Diagnostics determined invalid /low impedances on the scs system.Consequently, the scs system was explanted.The patient received two leads with the same lot number.
 
Manufacturer Narrative
(b)(4).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.
 
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Brand Name
EON RECHARGEABLE IPG, 16-CHANNEL
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston road
plano TX 75024
Manufacturer Contact
taruna sharma
MDR Report Key4566775
MDR Text Key5593844
Report Number1627487-2015-20144
Device Sequence Number1
Product Code GZB
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
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2009
Device Model Number3716
Device Lot Number112712
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age46 YR
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