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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 10/01/2012
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2012 reported that the patient presented for the vns follow up visit complaining of an increase in seizures. It was also indicated that the patient feels very depressed, but there was no indication of an increase in depression. The patient was referred for generator replacement due to neos=yes. Attempts for additional information have been unsuccessful to date. The patient had generator replacement surgery occurred on (b)(6) 2012. Attempts for product return are in progress, but the generator has not been received to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2835948
Report Number1644487-2012-03047
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/23/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2011
Device MODEL Number103
Device LOT Number2497
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/23/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2009
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: 11/16/2012 Patient Sequence Number: 1
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