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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 02/01/2010
Event Type  Injury  
Event Description

Reporter indicated that she was experiencing shortness of breath and chest pain, for which she went to the er. At the er it was found that she also had an elevated heart rate and decreased oxygen saturations. A number of tests were run which all confirmed that the issue was not likely heart or pulmonary related. Information was later received that the pt's neurologist decreased the pt's programmed output current which has resolved the issues, as per the pt.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1641399
Report Number1644487-2010-00710
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2011
Device MODEL Number103
Device LOT Number201218
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/22/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2009
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: 03/24/2010 Patient Sequence Number: 1
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