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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. GENERATOR

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CYBERONICS, INC. GENERATOR Back to Search Results
Device Problems High impedance; Adverse Event Without Identified Device or Use Problem
Event Date 03/10/2017
Event Type  Injury  
Event Description

It was reported by the physician that the patient was uncomfortable with stimulation and he had requested how to perform diagnostic testing. It was later explained the patient was experiencing a shocking sensation with stimulation and the physician had decreased the pulse width and the frequency due to the shocking sensation. The patient was also sent for z-rays. One x-ray ap image, which included the neck and chest, was reviewed. The vns generator was in the left chest, the feedthru wires appeared intact, and the lead wires connector pin could not be fully assessed due to the image quality. A strain relief bend was present, but the presence of a strain relief loop could not be determined. While no sharp angles or gross lead fractures could be visualized due to image quality, there was a potential suspect location near the neck. An additional suspect area was noted above the generator and slightly above an additional lead for a device not associated with vns. However, it should be stated that it is unclear if the suspect areas actually show an issue with the lead, or if the suspect areas are just artifact. Additionally, proper electrode placement could not be determined due to image quality. The cause of the reported painful stimulation could not be conclusively determined. While there were no gross fractures or sharp angles conclusively observed in the image, a portion of the lead behind the generator could not be assessed; therefore, a lead fracture in that portion cannot be ruled out. The presence of a micro-fracture in the lead also cannot be ruled out.

 
Event Description

It was further explained by the physician that the patient¿s pain stopped when the device was programmed off; however, the patient experienced an increase in seizures due to the device disablement, so the device was programmed back on. The physician also mentioned high impedance was observed. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NameNI
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 Key6459382
Report Number1644487-2017-03566
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/04/2017 Patient Sequence Number: 1
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