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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 01/01/2015
Event Type  Malfunction  
Event Description

It was reported that the patient's seizures are worse at times, but it is unknown whether or not the increase is above the patient's pre-vns baseline frequency. The patient believes that the generator battery is low. The patient reported that she still feels device stimulation, but that the seizures are changing and are more frequent at night. The patient reported that she has not been seen by the physician for a year and needs to find a new physician to have the device checked. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received stating that the vns patient had scheduled an appointment with a new physician to check the device but then cancelled the appointment. The patient has not been seen by a physician to date.

 
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Brand NamePULSE GEN MODEL 104
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 Key4627745
Report Number1644487-2015-04220
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 02/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2011
Device MODEL Number104
Device LOT Number2309
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/10/2009
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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