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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
Device Problem Insufficient Information (3190)
Patient Problems Syncope (1610); Bradycardia (1751)
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 Name
MODEL 105 GENERATOR
Type of Device
GENERATOR
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
MDR Text Key43509518
Report Number1644487-2016-00866
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 03/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Event Location Other
Initial Date Manufacturer Received 03/31/2016
Initial Date FDA Received04/22/2016
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age25 YR
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