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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 11/06/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device showed a high impedance condition (impedance value ¿ 9287 ohms) during an office visit on (b)(6) 2015. The patient¿s device was subsequently disabled. X-rays were taken and were reported by the physician to be unremarkable. Clinic notes were received indicating that the patient had been experiencing an increase in nighttime seizures in the past 1-2 months. The notes mention that the increase in seizures may be related to changes in medications that occurred around that time. The patient¿s medications were adjusted on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned generator and lead was completed. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. Discontinuity was observed in both positive and negative quadfilar coils in the body region of the returned lead portions where abraded openings were observed on the outer and both inner silicone tubes and tie down location. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.

 
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 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 Key4554444
Report Number1644487-2015-04001
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 02/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number302-20
Device LOT Number1176
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/21/2005
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: 02/27/2015 Patient Sequence Number: 1
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