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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Malfunction  
Event Description

It was reported by the patient that she has had an increase in seizures over the past month. She was concerned that her battery was depleted and was looking for a neurologist to check her device as it hasn't been checked in two years. No additional relevant information has been received to date.

 
Event Description

It was reported that the patient was seen by a physician. The device was checked and found to still have some battery life remaining. Information was received from the physician's office that the patient settings were increased due to the increase in seizures. The changes in settings were well tolerated per the physician.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7340863
Report Number1644487-2018-00396
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2013
Device MODEL Number103
Device LOT Number3134
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2011
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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