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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 03/06/2014
Event Type  Malfunction  
Event Description

Clinic notes were received on (b)(4) 2015 and dated (b)(6) 2014. Notes state that the patient¿s mom thinks seizures are worse and the patient's teacher thinks he is having breakthrough seizures. Notes dated (b)(6) 2015 state that the patient is doing well. Has had no seizures since (b)(6) 2014.

 
Event Description

It was reported from a nurse at the patient's physician's office that the patient was last seen on (b)(6) 2015 and has been doing great. She said that the increase in seizures back in 2014 was not at all thought to be related to vns. She said nothing was really done for intervention for that increase so it must have just improved on it's own.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4745626
Report Number1644487-2015-04604
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/03/2013
Device MODEL Number103
Device LOT Number201860
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/07/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/26/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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