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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem High impedance
Event Date 10/04/2017
Event Type  Malfunction  
Event Description

Report received that a patient's vns was interrogated and a system diagnostic was run which showed high impedance. The patient reportedly did not have any adverse events associated with the high impedance. The patient reportedly had a generator replacement about 11 months prior to the high impedance being present. X-rays were taken and returned to the manufacturer for analysis. The complete insertion of the connector pin into the connector block could not be accurately assessed because of the quality and angle of the image. The feedthru wires appeared fully intact. There appeared to be a strain relief bend present secured by two tie-downs. However, there was no strain relief loop present. A lead fracture was not identified in the image. The lead wire did appear to be fully connected at the connector pin. The electrodes appeared to be placed adjacent to one another instead of vertically. A review of the programing history did not indicate whether high impedance was present prior to this finding. There was reportedly no trauma that would have caused the high impedance. Surgical intervention has not occurred to date.

 
Event Description

Further information was received that the patient's lead was replaced. While in the or, it was found that the lead electrodes appeared to be off the nerve as the anchor tether was outside the carotid sheath. The lead was discarded after surgery. A review of the patient's last implant card showed that impedance was normal after the last generator replacement. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 303
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 Key6988483
Report Number1644487-2017-04706
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2012
Device MODEL Number303-20
Device LOT Number201016
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/09/2009
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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