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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 Corroded ; Fracture
Event Date 07/01/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the patient's device showed high impedance. The patient's device was also at a low battery indicator and was referred for a full revision surgery to address both events. Further information was received that the high impedance was first seen around the beginning of july according to the patient's mother. The physician's office had diagnostics recorded from earlier which were ok. There was no reported/observed traumatic event for the patient that could have led to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

 
Event Description

Additional information was received that the patient had a full revision surgery to replace the lead and generator. It was stated that high impedance was observed during pre-op diagnostics. It was stated the surgeon implanted the new lead on the right vagus nerve due to too much scar tissue on the left side. The explanted products have not been received by the manufacturer to date.

 
Event Description

The products were received and analysis was completed on the generator. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Event Description

Product analysis was completed on the lead. The lead was returned in 3 portions with one tie down attached. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. During continuity checks it was noted that the coil was broken close to the electrode bifurcation. The electrodes were not returned with this portion of the lead body. Sem was performed on the suspected coil break and it was noted that there was extensive pitting in the area making it not possible to identify the cause of the fracture. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

 
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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 Key6874986
Report Number1644487-2017-04474
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number302-20
Device LOT Number200931
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/10/2008
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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