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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 07/22/2015
Event Type  Injury  
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.Udi (di): (b)(4).
 
Event Description
It was reported the patient's ipg could no longer communicate with the external devices due to it being inoperable.A replacement charging system was sent to the patient but could not provide resolution.As a result, the patient will undergo surgical intervention.
 
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.
 
Event Description
Follow-up revealed x-rays were taken and showed no anomalies.Surgery remains pending.
 
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
Follow-up revealed the patient's ipg was explanted and replaced on (b)(6) 2015.The issue was resolved by surgical intervention.
 
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.
 
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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 Key5023535
MDR Text Key23794424
Report Number1627487-2015-07473
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Followup,Followup
Report Date 11/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2015
Device Model Number3788
Device Lot Number4037574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2015
Date Manufacturer Received11/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2013
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 Age50 YR
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