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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 Problems Failure to Charge (1085); No Device Output (1435); Failure to Deliver (2338)
Patient Problems Discomfort (2330); Weight Changes (2607)
Event Date 12/12/2014
Event Type  Injury  
Event Description
It was reported the ipg was unable to communicate with the external devices.The patient last recharged her ipg and received stimulation in (b)(6) 2014.In addition, the patient reports she has lost a significant amount of weight and feels as if the ipg is rolling inside the ipg pocket and is uncomfortable.X-rays were taken which revealed the ipg had flipped.The sjm representative confirmed the ipg is dead.Surgical intervention may be pending to address these issues.
 
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.
 
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 information identified the patient underwent surgical intervention to remove and replace her ipg which resolved the issue.
 
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 DIVISION
6901 preston road
plano TX 75024
MDR Report Key4834793
MDR Text Key5946546
Report Number1627487-2015-26248
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,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2015
Device Model Number3788
Device Lot Number3944523
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/22/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2013
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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