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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 01/07/2011
Event Type  Injury  
Event Description

Mfr received a report from a vns pt that after vns device magnet was swiped, her heart raced and she started coughing which lead her to shortness of breath. The review of mfr's programming history database showed that sys diagnostics results performed on the day of surgery, (b)(6) 2010, were within normal range. Mfr suggested the pt to see her treating neurologist. Good faith attempts to obtain more info from pt's treating 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 Key1979704
Report Number1644487-2011-00183
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number102
Device LOT Number201423
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/07/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2010
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: 02/03/2011 Patient Sequence Number: 1
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