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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 Nonstandard Device (1420); Device Stops Intermittently (1599); Temperature Problem (3022)
Patient Problems Device Overstimulation of Tissue (1991); Burning Sensation (2146)
Event Date 05/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Recall: 16271487-12192011-003-r. 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: 1627487-2016-03105. It was reported the patient was experiencing a burning sensation while recharging and intermittent overstimulation. The patient reports the overstimulation sensation occurs while lying in her bed and driving the car. In addition, the stimulation was intermittent. Follow up information identified the patient underwent surgical intervention on (b)(6) 2016 to remove and replace the ipg. On (b)(6) 2012 st. Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients. An increase in prior non-reported heating while charging events and other non-reported events was expected.
 
Event Description
Device #1 of 2: reference mfr. Report: 1627487-2016-03105.
 
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 2: reference mfr. Report: 1627487-2016-03105. Follow up information identified pocket heating has been resolved.
 
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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 Key5729128
MDR Text Key47518758
Report Number1627487-2016-03104
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 other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2013
Device Model Number3788
Device Lot Number3290712
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-07262012-002-R

Patient Treatment Data
Date Received: 06/16/2016 Patient Sequence Number: 1
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