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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a vns patient was experiencing painful stimulation to her face lasting 3-4 seconds 2 times per week at random time periods. The patient was referred for battery replacement. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Manufacturer Narrative

The information for the event description for follow-up report #1 was inadvertently not provided. The information for the device settings were inadvertently not provided in follow-up report #1.

 
Event Description

Follow-up from the physician provided that the results of the most recent diagnostics were normal. The replacement was provided to have been to prevent a serious injury and for patient comfort reasons. Generator replacement surgery occurred. The explanted generator was received (b)(6) 2017. Analysis is underway, but has not been completed to-date.

 
Manufacturer Narrative

 
Event Description

Analysis was completed for the returned generator. Analysis showed the battery was not depleted. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 103
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 Key6566111
Report Number1644487-2017-03795
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2012
Device MODEL Number103
Device LOT Number201534
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/23/2010
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: 05/14/2017 Patient Sequence Number: 1
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