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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 Fracture
Event Date 02/14/2018
Event Type  Malfunction  
Event Description

Upon interrogation of patient's vns, the lead impedance was reported to be greater than 10,000 ohms. The patient reported no trauma to the vns area. The neurologist disabled the generator and referred patient for lead replacement. No known surgical interventions have occurred to date.

 
Event Description

Patient underwent generator and lead replacement. Upon interrogating in the or the lead impedance remained above 10000 ohms. The surgeon opened the generator pocket and found that the lead was extremely coiled behind the generator. In an effort to extend the coil to access the lead body the lead severed in two. The surgeon removed as much of the old lead as possible and replaced the lead and the generator. The explanted devices were discarded. The lead was cut in several pieces to remove it.

 
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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 Key7315463
Report Number1644487-2018-00333
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number304-20
Device LOT Number2767
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/18/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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