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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 05/01/2009
Event Type  Injury  
Event Description

It was reported to manufacturer that the vns patient was recently experiencing a new seizure type and an increase in the pre-existing seizures, below the pre-vns baseline. The reporter indicated that the vns device is believed to be nearing end of service. A battery life calculation was performed with the available programming history and confirmed that the generator is likely at end of service. Good faith attempts to obtain additional information from the treating physician regarding the events have been made, but have been unsuccessful to date. The patient subsequently had surgery where the generator was replaced without incident. The explanted generator has been returned to manufacturer and the device analysis is underway.

 
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Brand NamePULSE GEN MODEL 102R
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1403970
Report Number1644487-2009-01237
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 05/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number102R
Device LOT Number015227
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer06/16/2009
Is The Reporter A Health Professional? No
Date Manufacturer Received05/20/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2006
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: 06/17/2009 Patient Sequence Number: 1
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