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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 05/27/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient was experiencing discomfort with stimulation in her throat. This was not ameliorated with attempts to lower settings. The physician expressed wanting to get the patient¿s vns explanted. Lead impedance was within normal limits, and review of x-rays by the physician did not show any obvious problems that could be causing or contributing to the painful stimulation. X-ray images taken after the onset of the painful stimulation were reviewed by the manufacturer. Ap and lateral x-rays of the neck and an odontoid view were included in the reviewed images. The generator was placed normally per labeling. The connector pin of the lead could not be fully assessed to be inserted inside the connector block due to the viewing angle and quality of the image. The feedthru wires appeared intact. The electrode placement appeared to be per device labeling. A small portion of the lead was behind the generator, making the lead difficult to assess in this area. There were no apparent sharp angles or gross fractures of the lead that could be seen in the images given. The wires at the lead connector pin appeared to be intact. No additional pertinent information has been received to date.

 
Event Description

Communication with the patient¿s treating physician showed that surgery was not to preclude a serious injury and was simply in relation to discomfort. Surgical intervention has not occurred to date, and no additional pertinent information has been received to date.

 
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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 Key6548498
Report Number1644487-2017-03729
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2015
Device MODEL Number103
Device LOT Number3602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2013
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: 05/05/2017 Patient Sequence Number: 1
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