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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Low impedance
Event Date 10/24/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

Report received that low impedance was observed on a patient's vns. A manufacturer representative followed up with the patient about a month later and ran system diagnostic tests. Low impedance was still seen. The patient reportedly denied having any recent injuries or trauma that could have damaged the lead. The physician increased the patient's settings where she reportedly felt a noticeable difference. She also had voice alteration at the higher settings. This indicated some stimulation was still being delivered to the vagus nerve despite the low impedance. A review of the device history record indicated the lead had passed all quality inspections prior to being release for distribution. No surgical intervention has occurred and no further relevant information has been received to date.

 
Manufacturer Narrative

Adverse event or product problem, corrected data: initial report inadvertently did not check adverse event. (b)(4).

 
Event Description

Further information was received from the patient's physician that there was no indication of any trauma or manipulation that might have occurred which could have led to low impedance. When the patient was seen on the day low impedance was first seen, the patient reportedly had discomfort in her throat with stimulation. The patient was reportedly seen at a later date. The system diagnostic test run on this day showed an impedance value within normal limits. There was no data available in the programming history for review and no additional data has been reviewed to date. No further relevant information has been received to date and no surgical intervention has occurred.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key7138842
Report Number1644487-2017-05063
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2017
Device MODEL Number304-20
Device LOT Number3680
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2013
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: 12/21/2017 Patient Sequence Number: 1
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