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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 Problems Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Edema (1820); Fall (1848); Inadequate Pain Relief (2388)
Event Type  Injury  
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
The patient reports he suffered a fall and landed on the ipg. After the fall the site was swollen and he was unable to recharge the ipg, however the swelling has now subsided and he is still unable to recharge the ipg. Troubleshooting determined the ipg is unable to communicate with multiple external devices. The patient last received therapy 4 months ago and the patient recharged once a week. Surgical intervention may be pending to address this issue.
 
Event Description
Follow up information identified the patient underwent surgical intervention on (b)(6)2017 where the entire scs system was explanted and replaced with a competitors system.
 
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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 Key6538356
MDR Text Key74221840
Report Number1627487-2017-02336
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 06/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2015
Device Model Number3716
Device Lot Number3983040
Other Device ID Number05414734402583
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
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