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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 No Device Output (1435)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/16/2016
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported the patient was without stimulation as the ipg had been inoperable for 3 years.Upon interrogation with an external programmer, a communication error was observed.The ipg was explanted and replaced.Postoperatively, the patient is reportedly receiving effective therapy.
 
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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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8676987
MDR Text Key147291698
Report Number1627487-2019-06578
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05414734402651
UDI-Public05414734402651
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 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/28/2013
Device Model Number3788
Device Catalogue Number3788
Device Lot Number3371406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2011
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 Weight73
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