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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 06/11/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested and diagnostic results were ¿abnormal¿ indicating a potential lead fracture. The patient refused to have her device disabled. It was noted that there was no change in the patient¿s seizure frequency. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(4) 2014. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin could not be confirmed to be fully inserted into the generator connector block. Part of the lead was 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. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.

 
Event Description

An implant card was received noting that the patient underwent lead and generator replacement due to lead discontinuity and an increase in seizures. The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Additional information was received clarifying that the reported ¿abnormal¿ diagnostic results were referring to diagnostic results from (b)(6) 2014 which revealed high impedance (dcdc ¿ 7). The suspected cause of the high impedance condition of the patient¿s device is believed to be due to trauma experienced from the patient¿s seizure activity. The physician attributed that the patient¿s increase in seizures was due to the high impedance condition of the device. Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead portions confirmed discontinuity of positive quadfilar coil in the electrode region. Scanning electron microscopy images of the positive coil broken ends show that pitting or electro-etching conditions have occurred at the break locations. The silicone tubing of the negative coil was found to be punctured open. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.

 
Manufacturer Narrative

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

 
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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 Key4082477
Report Number1644487-2014-02315
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/13/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2013
Device MODEL Number302-20
Device LOT Number2491
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/23/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/28/2009
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: 09/11/2014 Patient Sequence Number: 1
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