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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 06/15/2009
Event Type  Injury  
Event Description

Clinicals were received and reviewed at mfr. Notes reported that the pt had several admissions to the hosp for breakthrough seizures and grandmal seizures, diastat did not abort the pt's seizures. Medications were titrated. The pt had also been having a change in seizure type based on the pt's presentation during her seizures. It is unk if the pt's seizures are above their pre vns seizure rate. The pt will be scheduled to have a prophylactic generator replacement. Good faith attempts are being made for add'l details.

 
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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 Key1461374
Report Number1644487-2009-01867
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/03/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number102R
Device LOT Number011190
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/03/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2004
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: 09/01/2009 Patient Sequence Number: 1
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