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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 Programming Issue
Event Date 08/03/2012
Event Type  Injury  
Event Description

Clinic notes were received indicating that the vns patient's device settings were adjusted on (b)(6) 2013 and the patient tolerated the adjustment well. The physician commented that the patient's pulse width was programmed to low settings likely due to unspecified tolerability issues when the device was implanted. Programming history in the clinic notes showed that the device pulse width was programed to 250usec from (b)(6) 2014 through (b)(6) 2015. Review of the available programming and diagnostic history showed that the device pulse width was programmed to 250usec. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Follow-up revealed that the tolerability issues were referring to painful stimulation when the device pulse width was increased greater than 250usec. The pulse width was reduced back to 250usec. The physician did not consider this an issue but an expected side effect of device stimulation. System diagnostic results had shown normal device function throughout the years and the patient was doing well.

 
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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 Key5104072
Report Number1644487-2015-05896
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number103
Device LOT Number202085
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/21/2012
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: 09/25/2015 Patient Sequence Number: 1
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