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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 06/15/2009
Event Type  Injury  
Event Description

Additional information was received that the cyanosis and sleep apnea were not related to vns. The patient has been scheduled for treatment of the sleep apnea but does not follow-through with the treatment. The patient does have a history of sleep apnea pre-vns. In 2006 the lowest oxygen level was 79%.

 
Event Description

It was initially reported that the patient has a history of sleep apnea and cyanosis, unknown if related to vns. The patient has been reported to have not used her cpap machine since last year. Good faith attempt for more information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key2410533
Report Number1644487-2012-00080
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2004
Device MODEL Number102
Device LOT Number7541
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/13/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/19/2002
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: 01/11/2012 Patient Sequence Number: 1
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