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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2019
Event Type  Malfunction  
Event Description

It was reported that a patient was experiencing an increase in seizures following a battery replacement surgery, and the patient stated that this always occurs after a vns surgery. The device was programmed on and were at the patient's previous pre-surgery settings. Follow up with the physician's office indicated that there were no records that could be found or accessed regarding the patient experiencing an increase of seizures following any vns procedure. Further follow up was received from the physician's office after seeing the patient. It was uncertain if the increase in seizures were at, above, or below pre-vns baseline levels, but it was stated that they were worse than usual in the month before the vns replacement. Per the physician, the cause of the recent increase in seizures was not clear, but possibly related to surgery stress. The physician stated that they were not involved with previous vns surgeries, but it was reported that the patient had experienced an increase in seizures for 1 day. Settings and diagnostics were provided. No additional, relevant information was received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key8485779
Report Number1644487-2019-00659
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204727
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2018
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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