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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2002
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient's device was disabled due to painful stimulation in the left side of neck face and left arm. Since generator replacement, the patient also had pain due to position of device. Diagnostics of the device indicated normal device function and x-rays were taken. The patient therefore requested for device explant and the device was explanted. The device history records were reviewed and the records indicate that both the generator and lead passed all tests and inspections prior to shipment. The explanted devices were not received to date.

 
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Brand NamePULSE GEN MODEL 101
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 Key7143656
Report Number1644487-2017-05075
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/02/2003
Device MODEL Number101
Device LOT Number6350
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/09/2002
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: 12/22/2017 Patient Sequence Number: 1
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