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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

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CYBERONICS, INC. LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problems Mechanical Problem; Low impedance
Event Date 10/13/2017
Event Type  Malfunction  
Event Description

It was reported that when the patient's generator was replaced, low impedance was observed with an impedance value of <600 ohms. It was reported that the impedance value was okay on the patient's previous generator. When the patient's generator was replaced, the existing lead was noted to be intertwined in a glob-like fashion. The lead was then un-clumped prior to being inserted into the new generator. The lead was retained, and not replaced at this time. The provider suspects the tubing over the existing lead was compromised and this is the cause for the low impedance. The patient was seen in the clinic one week after surgery as was able to perceive stimulation. No known surgical intervention has occurred for the lead. No other relevant information has been received to date.

 
Event Description

It was reported that this patient underwent a full revision surgery. The products will not be returned for product analysis. No other relevant information has been received to date.

 
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Brand NameLEAD MODEL 300
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 Key7086291
Report Number1644487-2017-04938
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2003
Device MODEL Number300-20
Device LOT Number2802
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/12/2001
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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