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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 11/23/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

A patient's device was causing him discomfort. High lead impedance was observed on the patient's device. The patient also reportedly had an external skin wound that may have been caused by the vns. The patient's device was programmed off in response. X-rays were performed and reviewed by the physician and reportedly did not identify a lead break or other abnormality. A company representative reported that the pain may be a result of stimulation. The physician suspected that the patient's wound had become infected. At a subsequent visit, the patient's wound had improved significantly since the device was disabled. The company representative confirmed this via assessment of updated pictures of the wound. The patient was given antibiotics. Lateral neck x-rays of the patient's device were reviewed by the manufacturer. Only a small portion of the lead was visible in the images, and the generator was not visible in the x-ray images provided. The lead was observed in the neck. The strain relief bend was present, but a strain relief loop did not appear to be completed. Two tie-downs appeared to be securing the lead past the strain relief bend. No sharp angles or discontinuities were observed in the images. Ap neck and chest x-rays and lateral chest x-rays were later reviewed by the manufacturer. Due to the angle of the generator in the image, proper lead pin insertion could not be assessed. The filter feedthru wires appeared intact. The lead was observed in the neck, and the electrodes appeared to be placed per labeling. The strain relief bend was present, but a strain relief loop did not appear to be completed. No sharp angles or discontinuities were observed in the visible portion of the lead. A portion of the lead was routed behind the generator and could not be assessed. The cause of the patient¿s high impedance could not be determined with the x-ray images provided. The device history records were reviewed for the lead and generator and revealed that both devices met all sterilization and functional specifications for release prior to distribution. The physician did not believe that patient manipulation of the device caused the external wound and infection. The patient was referred for surgery to resolve the high impedance, but no surgical intervention has occurred to date. No additional relevant information has been received to date.

 
Event Description

The patient underwent exploratory surgery. It was determined that fluid was observed in the lead, causing the surgeon to suspect a lead fracture. High impedance was observed on both system and normal mode diagnostic tests. The patient was referred for lead and generator replacement surgery, but no additional surgical intervention has occurred to date. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
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 Key7132107
Report Number1644487-2017-05046
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/22/2017
Device MODEL Number302-20
Device LOT Number3604
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/25/2013
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: 12/19/2017 Patient Sequence Number: 1
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