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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 02/09/2010
Event Type  Injury  
Event Description

It was reported by the vns pt's mother, that the vns pt, who was implanted with the device on (b) (6) 2010, had experienced a syncope event, was very pale, not stable on his legs, and appeared lethargic. The device had not been programmed on at the time of the report of the events. Follow up with the treating physician revealed that the relationship of the syncope event to surgery/vns is unk, however, it was noted that the pt does not have a pre-existing history of syncope events. Additionally, it was noted that the pt "has autism and every change in his life is very difficult for him" and that the pallor, a lethargy were "probably not related to vns". No interventions have been taken for the events, the device has been programmed on, and the physician is in the process of titrating the settings up to therapeutic settings.

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE 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 Key1631437
Report Number1644487-2010-00599
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2011
Device MODEL Number103
Device LOT Number201194
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/10/2010
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: 03/12/2010 Patient Sequence Number: 1
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