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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 01/01/2012
Event Type  Injury  
Event Description

All attempts to the reporter's treating neurologist for further information have been unsuccessful to date.

 
Event Description

Reporter indicated that since his vns settings were increased in (b)(6) 2012, he had been experiencing dyspnea and "heart racing. " the reporter was advised to follow up with his physician. Manufacturer follow up with the treating physician revealed the reporter had not notified the physician about the reported issues. The physician will attempt to follow up with the reporter. Attempts for further information are in progress.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2507314
Report Number1644487-2012-00838
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/01/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/31/2009
Device MODEL Number102
Device LOT Number1940
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/04/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/18/2007
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: 03/28/2012 Patient Sequence Number: 1
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