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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
Event Date 10/06/2015
Event Type  Malfunction  
Event Description

It was reported that vns system implanted in the patient was tested and system diagnostics returned high impedance with dcdc code 7 and neos no. X-rays were taken and sent to the manufacturer for review. The generator appears to be placed under the right arm in an abnormal arrangement. The filter feed-through wires appears to be intact. The insertion of the lead-pin connector could not be fully assessed due to the orientation of the generator in the x-rays and the quality of images, it appears to be not fully inserted. The electrodes appeared to be placed in abnormal arrangement, not in the neck. A strain-relief bend and a loop were not used. Only one tie-down was found holding the upper lead body. Part of the lead appeared to be behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. It was reported by the physician that the device was not switched off yet. No known surgical interventions have occurred to date. No patient adverse events were reported to date.

 
Event Description

Further information was received from the facility, indicating that the patient underwent full replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity and the generator was prophylactically replaced. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. It was reported that the explanted devices will not be returned to the manufacturer as they were discarded. Therefore, no analysis results could be provided. No additional information was provided 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 Key5194237
Report Number1644487-2015-06295
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 10/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2014
Device MODEL Number302-20
Device LOT Number2837
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/10/2010
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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