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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 12/18/2013
Event Type  Malfunction  
Event Description

It was reported that device diagnostics on the physician's handheld showed high impedance. It is unknown if the device was programmed off after observing the high impedance reading. It is unknown if x-rays were taken or if any patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance reading. Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the device has been programmed off, and there are no plans to replace vns at this time.

 
Event Description

The patient was referred for explant surgery because of the high impedance. The patient had explant surgery on (b)(6) 2016. The explanted product has not been received to date.

 
Event Description

The explanted lead and generator were received. Analysis has not been approved to date.

 
Event Description

Analysis of the generator and lead were approved. There was evidence of high impedance in the generator memory. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored, and the pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 938 volts as measured, showed an ifi=no condition. The data in memory locations revealed that 51. 929% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Scanning electron microscopy images of the negative coil of the lead showed that pitting or electro-etching conditions occurred on the discolored surfaces of the negative coil wires. Also, one strand of the negative quadfilar coil showed appearance of what appeared to be wear (flat surfaces) and scratches on the surface. The reason for this condition was unknown. Although difficult to state conclusively, the most likely cause for the observed electro-etching condition was a pulse generator attempting to deliver therapy through an exposed coil and/or an open electrical load. However, no openings were noted on the outer or the inner silicone tubing of the lead coils of the returned lead portion of the lead. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
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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 Key3578801
Report Number1644487-2014-00256
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/20/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2006
Device MODEL Number302-20
Device LOT Number011314
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/11/2004
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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