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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 04/04/2011
Event Type  Injury  
Event Description

It was reported by a vns pt that after she allergic reaction to antibiotics prescribed by neurosurgeon, captured in mdr# 1644487-2011-00975, she was told by hospital physician that she has an abnormal ekg. She was referred to cardiologist but the name of cardiologist was not provided. Good faith attempts to obtain additional information from pt's neurologist have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2082987
Report Number1644487-2011-00976
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 04/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date08/31/2011
Device MODEL Number102
Device LOT Number2561
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/11/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2010
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: 05/04/2011 Patient Sequence Number: 1
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