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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Low impedance
Event Date 06/27/2019
Event Type  Malfunction  
Event Description

It was reported that a patient's device has low impedance and that there are no complaints from the patient. Anteroposterior and lateral chest x-rays were received and reviewed. Per the images received, the connector pin insertion cannot be assessed due to the quality and angle of the image. The placement of the generator is normal. The feed thru wires do not seem intact at the connector pin and appeared bent. The lead was located behind the generator and the lead wires at the connector pins could not be assessed due to the quality and angle of the image. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There is no strain relief loop or bend present. One tie-down was visualized and not placed per labeling - tie down and lead were not located parallel to the electrodes. No gross fractures were visualized however a sharp angle was seen, directly below the electrodes, and appears to be looped over itself. Based on the x-rays received, the cause of the low impedance cannot be determined, as no obvious short circuit condition could be visualized. The sharp angle below the electrode and the bent feed through wires cannot be ruled out as possible causes, however, cannot be confirmed to be reasons for the low impedance. A possible fracture or short circuit in the part of the lead that was not able to be visualized in the x-ray images and also cannot be ruled out. No surgical intervention has been reported to date. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8798633
Report Number1644487-2019-01383
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/10/2016
Device MODEL Number304-20
Device LOT Number202107
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/12/2012
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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