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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury  
Event Description

It was reported that a patient was experiencing blackouts, which he attributed to his vns being programmed to maximum settings. The patient could not remember if he had blackouts prior to vns. The patient stated that his surgeon informed him that vns can cause blackouts, believing that consecutive seizures coupled with maximum settings were the cause of his blackouts. The patient stated that his blackouts began two years prior. It was later reported that the physician's office had not evaluated the patient in regards to his blackouts. The nurse suggested that the blackouts could potentially be related to the patient's seizure condition, but she was unsure since the office had not evaluated the patient. No additional information has been provided to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key6446752
Report Number1644487-2017-03517
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/14/2017
Device MODEL Number102
Device LOT Number203260
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/05/2015
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: 03/30/2017 Patient Sequence Number: 1
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