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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 Stops Intermittently (1599); Impedance Problem (2950)
Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
(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. (b)(4).
 
Event Description
Device #1 of 2: reference mfr. Report: 1627487-2016-03748, the lead information is unknown. It was reported ((b)(6)) the patient is experiencing a sudden loss of power occurring 1-5 times a day. When the power loss occurs the patient experiences overstimulation in his back at the anchor site. Lead diagnostics revealed multiple invalid impedances. Surgical intervention may be pending to address this issue.
 
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
Device #1 of 3: reference mfr. Report: 1627487-2016-0348 and 1627487-2016-04826.
 
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
Device #1 of 3: reference mfr. Report: 1627487-2016-03448 and 1627487-2016-04826. 0 follow up information identified the patient underwent surgical intervention on (b)(6) 2016 to remove and replace the extension which resolved the issue. Therapy has been restored.
 
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Brand NameEON MINI IPG, 16-CHANNEL RECHARGEABLE
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 Key5805481
MDR Text Key49895078
Report Number1627487-2016-03447
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2014
Device Model Number3788
Device Lot Number3857384
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 Received09/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2012
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: 07/19/2016 Patient Sequence Number: 1
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