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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
Event Date 08/03/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a patient was not receiving efficacy from the vns device. It was later reported that the patient's mother believed the vns device was making the patient's seizures worse. The device history record for the implanted generator showed that the generator had passed all quality inspections prior to release for distribution. Post-op impedance values for the device were also within normal limits, indicating the device was working as intended after surgery. No further relevant information has been received to date. No surgical intervention has occurred 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5910302
Report Number1644487-2016-01945
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/06/2016
Device MODEL Number103
Device LOT Number203163
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/03/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/14/2014
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: 08/29/2016 Patient Sequence Number: 1
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