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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 04/01/2015
Event Type  Malfunction  
Event Description

It was reported by the company representative that the device is not neos = yes (near end of service), but is still at ifi = yes (intensified follow-up indicator), and is still showing yellow. No known surgical interventions have occurred to date.

 
Event Description

It was later reported the patient is having a big increase in seizures and the device is at near end-of-service.

 
Event Description

It was reported that the patient's replacement never occurred and he has now been referred for generator replacement due to neos (near end of service). The new referral due to neos indicates that the patient was most likely not at neos when the increase in seizures was first reported as the initial report was over 1 year ago. No known surgical interventions have been performed to date.

 
Manufacturer Narrative

 
Event Description

It was noted the patient was referred for a model 106 generator replacement as the patient is at a great risk for sudep. The patient was referred for generator replacement surgery; however, no know surgical interventions have been occurred to date.

 
Event Description

It was reported that the patient's seizures have been increasing. The physician feels that the patient's device may be nearing end of service. The patient was referred to surgeon. It is unknown whether or not the increase in seizures was above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4771856
Report Number1644487-2015-04706
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 01/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number3305
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/19/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2012
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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