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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 07/05/2011
Event Type  Injury  
Event Description

It was reported that the pt is currently experiencing an increase in seizures which is believed to be related to device end of svc as eri was showing yes. However, it was also noted in clinic notes that the pt was experiencing an increase in seizures prior to the device showing eri = yes. In (b)(6) 2011, the pt was "having a few more daytime seizures" which had been happening for the past 3 months. The increase was noted as being "slight". Her medications were increased slightly to address the increase. At a visit on (b)(6) 2011, it was noted that the eri = no, so it is likely that the increased seizures began prior to eri = yes. Attempts for further info have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key2196990
Report Number1644487-2011-01783
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102R
Device LOT Number015709
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/07/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
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: 08/04/2011 Patient Sequence Number: 1
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