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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/13/2001
Event Type  Injury  
Event Description

The patient was referred for the removal of the vns device as the patient believes the device chokes the them when it stimulates. Programming history was reviewed, and the patient¿s device was disabled on (b)(6) 2002. The last diagnostics showed good impedance. No indications of a device malfunction were identified in the programming history. The patient's device had previously been disabled due to choking and coughing. Per clinic notes, the vns had not helped to decrease the patient¿s frequent seizures of having 1-2 seizures per week. The patient was also said to be having swallowing issues. A second office reported that the patient did not have any discomfort when the device was programmed off. It was reported that the patient was referred for removal in order to allow for mri imaging, however it had previously been reported that the patient was referred for removal due to the feeling of choking so the reason for the patient's removal surgery is unknown. No relevant surgical intervention has occurred to date. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 101
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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8514622
Report Number1644487-2019-00723
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2002
Device MODEL Number101
Device LOT Number3535
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/21/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2001
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: 04/15/2019 Patient Sequence Number: 1
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