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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON MODEL 105 GENERATOR

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CYBERONICS - HOUSTON MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 10/01/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a patient began developing bradycardia and syncope 5 months prior. The syncope occurred several times per hour. The physician stated the bradycardia and syncope are most likely related to one another, but the relationship to vns was not confirmed. The events began when the patient's device settings were increased to normal mode: 1. 0ma/30hz/250usec/30sec/1. 1min magnet mode: 1. 25ma/250usec/60sec. No recent diagnostic tests have been performed. It was reported that using the magnet to turn off stimulation caused the events to cease. The physician changed the programmed the device off (0ma) on (b)(6) 2016 to verify if vns caused the event.

 
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Brand NameMODEL 105 GENERATOR
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 Key5600029
Report Number1644487-2016-00866
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 03/31/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/08/2016
Device MODEL Number105
Device LOT Number203209
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/31/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/06/2015
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: 04/22/2016 Patient Sequence Number: 1
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