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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 Device Inoperable (1663); Communication or Transmission Problem (2896)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/29/2018
Event Type  Injury  
Manufacturer Narrative
The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
 
Event Description
It was reported the patient no longer had therapy due to difficulty with charging.As a result, surgery is pending to have the ipg replaced.
 
Event Description
Follow up revealed that the patient underwent surgical intervention to have their ipg replaced.
 
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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
Manufacturer Contact
jason baker
6901 preston road
plano, TX 75024
9725268292
MDR Report Key7621950
MDR Text Key111763122
Report Number1627487-2018-05890
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734402323
UDI-Public05414734402323
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,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2015
Device Model Number3788
Device Lot Number4120906
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/29/2018
Initial Date FDA Received06/20/2018
Supplement Dates Manufacturer Received07/03/2018
Supplement Dates FDA Received07/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODEL 1194, SCS ANCHOR (2); MODEL 3228, SCS LEAD; MODEL 3383, SCS EXTENSION
Patient Outcome(s) Other;
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