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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 07/21/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the vns patient was experiencing painful, erratic stimulation from her device. Clinic notes were received indicating that the patient's device showed normal device function and an ifi condition during an office with on (b)(6) 2015. The patient presented with a sore throat which involved occasional pain in the throat from stimulation on-times. The physician attributed the issues to the device nearing end of service and referred the patient for surgery. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator has not been returned to date.

 
Manufacturer Narrative

Event description; corrected data: the previously submitted mdr inadvertently did not specify the pain associated with stimulation in the patient¿s neck and left arm.

 
Event Description

It was reported that the patient experienced pain associated with stimulation in her neck and left arm. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

 
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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 Key5006390
Report Number1644487-2015-05509
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 07/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2012
Device MODEL Number103
Device LOT Number2773
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/24/2010
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: 08/15/2015 Patient Sequence Number: 1
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