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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 06/15/2010
Event Type  Injury  
Event Description

Additional information was received that it was unknown when the patient's sleep apnea first occurred. It was not known or documented that it occurred with stimulation. The patient had a sleep evaluation performed on (b)(6) 2010 and is now on a cpap machine.

 
Event Description

Clinic notes were received for review from a vns patient's office visit dated (b)(6) 2010. It was reported that a vns patient's husband had noted snoring, apnea, and prominent abdominal movements with her sleep breathing and she will be referred to a sleep clinic for a sleep apnea evaluation. Good faith attempts thus far have not yielded any further information about the reported event and the relationship to their vns.

 
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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 Key2434788
Report Number1644487-2012-00245
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014277
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date02/17/2012
Event Location Other
Date Manufacturer Received02/17/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/13/2005
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: 02/01/2012 Patient Sequence Number: 1
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