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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 02/22/2011
Event Type  Injury  
Event Description

It was reported in the pt's clinic notes on (b)(6) 2011 that the pt had a "harder and longer" seizure, during which the pt stopped breathing for 45-50 seconds and became cyanotic. The physician also commented that it was "clear that the staff was able to swipe [the vns] magnet. " the pt's settings and diagnostic info from this date were given, and the device was shown to be properly functioning. Attempts for further info have been unsuccessful.

 
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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 Key2329459
Report Number1644487-2011-02613
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 10/14/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/30/2005
Device MODEL Number102
Device LOT Number010220
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/14/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2004
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: 11/02/2011 Patient Sequence Number: 1
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