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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 Problems Detachment Of Device Component; Fracture
Event Date 04/27/2017
Event Type  Malfunction  
Event Description

It was reported that a neurologist observed high impedance on a patient's device during a clinic visit. The neurologist reported that high impedance was not observed during the previous clinic visit (b)(6) prior. The patient's family also reported that she had fallen during her seizures. The patient was referred for surgery. No additional relevant information has been provided to date. No surgical intervention has occurred to date.

 
Event Description

The patient's father reported that the patient was experiencing an increase in seizures due to the high impedance. According to the patient's father, the surgeon believed that the lead may have become dislodged from the patient's vagus nerve. The patient underwent full revision surgery. The surgeon and company representative confirmed that the electrode had become dislodged from the nerve, but the surgeon did not know what caused the electrode to come off of the nerve. The explanted lead and generator were discarded and are unavailable for analysis. No additional relevant information has been received to date.

 
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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 Key6586456
Report Number1644487-2017-03865
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2018
Device MODEL Number304-20
Device LOT Number202923
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/08/2014
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: 05/23/2017 Patient Sequence Number: 1
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