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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 12/23/2015
Event Type  Malfunction  
Event Description

The patient reported that she is experiencing an increase in seizures as well as change in seizure pattern. She now states that her seizures appear to have an abdominal component as her stomach is upset with her seizures. No additional relevant information has been received to date.

 
Event Description

It was reported that the patient is concerned that her vns may need replacement due to seizure activity. She believes her current output current is 3. 5 ma. No additional relevant information has been received to date.

 
Event Description

Patient reported that she has been having breakthrough seizures and is wondering if her vns is going out. Patient also said that she has been sick with the flu and is not eating. Patient also mentioned that her magnet is not working as well. No additional relevant information has been received.

 
Event Description

The physician reported the patient's settings and diagnostics and the device was functioning properly. The physician does not believe the increase in seizures for the patient is related to the vns but rather environmental or social factors. The patient was given new magnets and was shown the proper technique for activating the device. The magnet activation was shown to provide stimulation as intended.

 
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Brand NamePULSE GEN MODEL 105
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5370584
Report Number1644487-2016-00117
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PATIENT
Type of Report Followup,Followup,Followup
Report Date 05/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2014
Device MODEL Number105
Device LOT Number202019
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2012
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: 01/15/2016 Patient Sequence Number: 1
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