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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL UNKNOWN

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CYBERONICS - HOUSTON LEAD MODEL UNKNOWN Back to Search Results
Device Problems Fluid Leak; Fracture; High impedance
Event Date 11/18/2016
Event Type  Malfunction  
Event Description

An article entitled "vagus nerve stimulation removal or replacement involving the lead and the electrode: surgical technique, institutional experience and outcome" was sent to the manufacturer and reviewed. During review of the article, multiple reportable events were identified. The article stated that 6 patients had replacement surgeries due to broken wires (lead fractures), and 5 patients had lead surgery due to degradation of the silicone tubing causing high impedance. Of these events, 3 lead fractures and 2 cases of tubing degradation were unable to be identified as previously reported. The patients who had high impedance and lead fractures also reportedly had an increase in seizures due to the device issue. One of the patients who had a lead replacement surgery due to a lead fracture had the replacement lead implanted on the right vagus nerve. This, caused the patient pain and the device had to be removed as a result. The article also contains references to other reportable events for generators which is captured in mfr report number. Additionally, the article stated that a patient had passed away due to sudep which is captured in mfr. Report 1644487-2017-03151. One unknown generator malfunction is reported in mfr. Report 1644487-2017-03153.

 
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Brand NameLEAD MODEL UNKNOWN
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6309080
Report Number1644487-2017-03152
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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 Received01/10/2017
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: 02/07/2017 Patient Sequence Number: 1
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