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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 01/01/2010
Event Type  Injury  
Event Description

It was reported to the mfr that the vns pt has been experiencing discomfort at the device site in the neck. The pt's device has also migrated from the chest to the arm pit area due to recent weight loss. The pt's device has been disabled in 2004 due to an increase in seizure activity (refer to mfr report #1644487-2010-00408). The pt's generator was explanted with no plans for replacement due to the reported irritation and lack of efficacy. The explanted generator has been returned to the mfr for analysis. Product analysis is currently underway. Good faith attempts to obtain add'l info regarding the reported events have been unsuccessful to date.

 
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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 Key1615471
Report Number1644487-2010-00409
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/22/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2004
Device MODEL Number102
Device LOT Number6575
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/01/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/22/2010
Was Device Evaluated By Manufacturer? No
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: 02/19/2010 Patient Sequence Number: 1
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