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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
Event Date 05/04/2015
Event Type  Malfunction  
Event Description

The patient underwent full explant on (b)(6) 2015. Per the surgeon, the scar tissue and remaining length of the nerve were such that re-implantation could not be completed. The patient is currently seizure free with her current medication regimen so at this point the patient is going to continue with clinical management and not pursue right sided vns placement at this time. The explanted devices are not available for return therefore product analysis will not be completed.

 
Event Description

The patient¿s mother reported on (b)(6) 2015 that the patient has had poor seizure control lately, and that she was hospitalized over the prior few days. She was admitted to the hospital. At that time, the vns was checked and x-rays were taken. The mother reported that she was told that there may have been an issue with the patient¿s vns leads. Additional information was later received that diagnostics confirmed high impedance on (b)(6) 2015, and the device was subsequently turned off. The patient's mother said seizures increased once "medicines started being adjusted. " the surgeon reported that the x-ray appears to show a kinking-issue with the lead. It was reported that there appears to be a slight fracture above the superficial strain relief loop near the sternocleidomastoid muscle. The surgeon suspected that the lead may have gotten kinked and subsequently fractured. No known surgical intervention has occurred to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
Event Description

On (b)(6) 2016 it was reported that the patient under went a full right-sided nerve placement and left chest placement of the vagal nerve stimulator.

 
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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 Key4767189
Report Number1644487-2015-04681
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2015
Device MODEL Number304-20
Device LOT Number3123
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/04/2011
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: 05/12/2015 Patient Sequence Number: 1
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