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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG Back to Search Results
Model Number 3716
Device Problem Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Type  malfunction  
Manufacturer Narrative
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. Manufacturer defers to the patient's physician regarding medical history.
 
Event Description
It was reported the patient failed to charge the ipg as recommended. The patient programmer displayed error 2501. The ipg was deemed inoperable. Surgical intervention maybe taken at a later date to address the issue.
 
Event Description
Additional information, identified the patient underwent surgical intervention wherein the ipg was explanted and replaced which resolved the issue. Effective therapy was established post operatively.
 
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Brand NameEON RECHARGEABLE IPG, 16-CHANNEL
Type of DeviceSCS 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 Key7523898
MDR Text Key108620245
Report Number1627487-2018-04949
Device Sequence Number1
Product Code LGW
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2009
Device Model Number3716
Device Catalogue Number3716
Device Lot Number69191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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