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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG Back to Search Results
Model Number 3688
Device Problem Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 06/04/2015
Event Type  Injury  
Event Description
It was reported the patient is experiencing pain at the ipg site.It was also reported the patient's ipg had partially flipped in the pocket and was moved back into the proper position non-surgically.The patient will meet with the physician as the next course of action.
 
Manufacturer Narrative
Udi (di): (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 information revealed the patient met with physician on (b)(6) 2015 and determined surgical intervention would be undertaken as the next course of action.Further follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015, where the patient's entire scs system was explanted.
 
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.
 
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Brand Name
EON C 16-CHANNEL IPG
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 Key4880424
MDR Text Key5863826
Report Number1627487-2015-23357
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,Followup
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/28/2016
Device Model Number3688
Device Lot Number4410167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2014
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 Age66 YR
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