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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 02/21/2019
Event Type  Injury  
Event Description

It was reported that a patient was having bradycardia after two years of vns treatment, with their first episode detected in (b)(6) 2019, with ventricular asystole of 15s and subsequent episodes of bradycardia. The output current was deceased and no episodes were then detected. It was stated that recently, the patient had episodes of bradycardia again and the neurologist decreased the output current and frequency. Further information was received that the patient was experiencing syncope-like episodes and appeared to be hospitalized due to this. The patient did not experience any traumatic events prior to the arrhythmia, and the patient did not have any triggers prior to the arrhythmia. It was stated that heart rate was provided prior to the event and during the event to be 84/min and 43/min respectively. It was stated that the arrhythmia does not correlate with the on time of the programmed device settings and the arrhythmia did not occur while performing system diagnostics. The arrhythmia did occur following a setting change. Following the findings from the ecg, the physician decided to decrease the device output parameters. The patient's seizures were well controlled with vns and aeds, but was admitted to the institution again due to syncope-like episodes and bradycardia in (b)(6) 2019. The physician did not find correlation between duty cycles of vns and bradycardia. It is stated that the arrhythmia is believed to be related to the vns therapy stimulation and that the vns stimulation exacerbated or co-currently contributed to the arrhythmia. It was also stated that the believed relationship between the vns and the bradycardia is due to high settings. In consultation with cardiologist, the vns was disabled. After the vns was disabled, the patient is neurologically stable, without seizures, and his repeated ecg reveals normal sinus rhythm. No additional 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 Key8842887
Report Number1644487-2019-01473
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/05/2019
Device MODEL Number103
Device LOT Number204177
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/18/2017
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: 07/30/2019 Patient Sequence Number: 1
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