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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 10/25/2014
Event Type  Malfunction  
Event Description

Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). It was noted that the patient had been experiencing an increase in seizures. The patient underwent generator and lead replacement surgery on 01/02/2015. The explanted devices have not been returned to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to a death.

 
Event Description

Additional information was received that no patient manipulation or trauma was known to have occurred which may have contributed to the high impedance. The explanted generator and lead were received for analysis. Analysis of the explanted generator showed proper functionality of the pulse generator in its ability to provide appropriate programmed output currents. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the generator's internal data showed that the high impedance occurred sometime on or prior to (b)(6) 2014. Analysis of the explanted lead was completed and confirmed discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both the outer and inner tubing were observed as well, which provided paths for the observed fluid leaks. Furthermore, pitting was observed near the break locations. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
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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 Key4430468
Report Number1644487-2015-03653
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/23/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2010
Device MODEL Number302-20
Device LOT Number1925
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/13/2007
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: 01/19/2015 Patient Sequence Number: 1
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