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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient woke up one day and was experiencing severe pain in the chest and neck. There was no known trauma to the vns and the neurologist didn't know what the cause was. The patient's settings were lowered and x-rays were ordered. Clinic notes indicated the patient patient's mother had called and reported that the patient was having severe chest pain and the patient was given fentanyl en route. A chest x-ray was unremarkable. A neurologist disabled her normal mode output current. Post pain medications and device disablement , the pain went away with no recurrence. The pain appeared to be prominently in the left side of the chest but also went into her neck and lower trunk region. The patient's mother indicated that the patient's pain was cyclical. There was no recent trauma to the head, neck and chest, and no patient manipulation. When the vns was turned on to 0. 5 ma the patient began to experience pain again, and her device was re-disabled. It was believed that the patient's pain was related to stimulation. The patient's device was reportedly working properly with good impedances. The physician believed that the patient's generator and leads may need to be replaced. The pain was reported to be serious. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

 
Event Description

The patient's generator and lead were replaced. The explanted products were discarded. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6858790
Report Number1644487-2017-04442
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/20/2016
Device MODEL Number105
Device LOT Number203181
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/04/2014
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: 09/12/2017 Patient Sequence Number: 1
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