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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/15/2015
Event Type  Malfunction  
Event Description

Received clinic notes as part of the process for a prophylactic generator replacement referral. Clinic notes dated (b)(6) 2015 report that the patient had alleged that they feel that their seizure frequency has increased since getting the vns. The patient noted that magnets near the vns actually trigger their small seizures rather than reducing them. At this same appointment, the physician noted in their assessment that overall the patient's seizure frequency has been stable for the past 2 years. The physician also programmed the vns output current higher, and noted that the patient appeared to tolerate the adjustment well without adverse effects. There were several appointments following the patient's visit on (b)(6) 2015 where it is noted that the patient's vagal nerve stimulator appeared to be working well. Additionally, the patient had reported using the magnet a couple of times and it seems to be working well for them. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key8389561
Report Number1644487-2019-00375
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/27/2014
Device MODEL Number103
Device LOT Number3391
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/07/2012
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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