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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 302-30
Event Date 09/11/2010
Event Type  Malfunction  
Event Description

It was reported by the treating physician hat the patient¿s device was turned off for patient comfort reasons in (b)(6) 2010 due to adverse events associated with delivery of stimulation. After disablement, the symptoms resolved. The physician reported in (b)(6) 2010 that the vns was reported to be working properly. However, it was recently reported by the surgeon¿s office that the patient¿s device had been disabled. They reported that according to the patient, she was having an increase in seizures because the device seemed "stuck" in the on position and would not stop stimulating. The device was subsequently programmed off. Good faith attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not update this information. Brand name, corrected data: the supplemental report #1 inadvertently did not update this information. Type of device name, corrected data: the supplemental report #1 inadvertently did not update this information. Model #, serial #, lot #, expiration date, corrected data: the supplemental report #1 inadvertently did not update this information. Type of reportable event, corrected data: the supplemental report #1 inadvertently did not update this information. Device manufacturer date, corrected data: the supplemental report #1 inadvertently did not update this information.

 
Event Description

Analysis of the generator and lead were completed. Abraded openings were identified in the inner and the outer silicone tubing of the lead resulting in portion of the lead coils being exposed. Also, the positive coil shows wear (flat surfaces) on the exposed surface. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot 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. In the analysis lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. 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.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death. Manufacturer device history records were reviewed. Review of device manufacturer records of the suspect device confirmed all quality tests were passed prior to distribution.

 
Event Description

The treating physician at the time of events is unable to provide further information. The patient had generator and lead explant on (b)(6) 2015 due to uncomfortable stimulation. The lead was cut. Upon explant, abraded insulation was observed and possible fluid leaks. The tc reported that a "black spot" was found in the lead tubing. The explanted devices were received by the manufacturer. However, analysis has not been completed to date.

 
Manufacturer Narrative

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4492174
Report Number1644487-2015-03772
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 01/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number302-30
Device LOT Number200556
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/23/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/17/2007
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: 02/06/2015 Patient Sequence Number: 1
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