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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Insufficient Information
Event Date 10/17/2013
Event Type  Malfunction  
Event Description

It was reported from the patient that since his replacement in 2013 he has had severe pain and discomfort. He states that the physician initially said it might be nerve damage. The patient noted he was in and out of the hospital due to chest pains and burning in his chest and neck, so he states the vns was tested and found to be malfunctioning. The patient stated the device has been programmed off since 2015. The patient would like to have the device removed but no known surgical intervention has occurred to date. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7784814
Report Number1644487-2018-01404
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2015
Device MODEL Number105
Device LOT Number3745
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/17/2013
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: 08/15/2018 Patient Sequence Number: 1
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