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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION DIVISION EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR

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ST JUDE MEDICAL - NEUROMODULATION DIVISION EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number 3788
Event Date 11/22/2010
Event Type  Injury  
Event Description

The patient received her scs system on (b)(6) 2010. It was reported that the patient experienced pain at her ipg pocket site after she was assaulted. The patient stated she needed to recharge her ipg more frequently. The ipg pocket was revised, but afterward the ipg was unable to communicate with the charger. A replacement charger did not resolve the issue. Follow up on the patient reported that the patient's ipg was explanted and replaced on (b)(6) 2010. The explanted ipg was returned to the manufacturer for evaluation on (b)(6) 2010. The patient reported effective stimulation after the replacement procedure.

 
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.

 
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Brand NameEON MINI RECHARGEABLE IPG
Type of DeviceTOTALLY IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
ST JUDE MEDICAL - NEUROMODULATION DIVISION
plano TX
Manufacturer Contact
paige sovern
6901 preston rd.
plano , TX 75024
9725264631
MDR Report Key1940425
Report Number1627487-2010-03839
Device Sequence Number1
Product CodeLGW
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 11/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2012
Device MODEL Number3788
Device LOT Number2929931
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/10/2010
Is The Reporter A Health Professional? No
Date Manufacturer Received11/22/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2010
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: 12/20/2010 Patient Sequence Number: 1
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