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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 01/01/2011
Event Type  Injury  
Event Description

It was reported via clinic notes that the patient's "seizures were under good control until (b)(6) 2011 when she started noticing spells involving confustion and staring. " the patient's amplitude setting was increased and the patient will be referred for prophylactic generator replacement. Attempts for further information have been unsuccessful to date.

 
Event Description

Additional information was received indicating that the patient's generator was replaced. Product has been requested, but has not been returned to the manufacturer to date.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2257025
Report Number1644487-2011-02203
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/17/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number012704
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/21/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2005
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: 09/16/2011 Patient Sequence Number: 1
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