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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 08/21/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device showed high impedance (impedance value >= 10,000 ohms). Clinic notes were received indicating that the patient had been experiencing an increase in seizure frequency and duration for the past three weeks prior to the office visit on (b)(6) 2014. The patient normally had 5-6 brief seizures per day or per week; however, the patient was having seizures that lasted up to five minutes and took longer to break down. It was noted that the patient gained the best seizure control with vns. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. The explanted devices have not been returned to date.

 
Manufacturer Narrative

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

 
Event Description

The explanted generator and lead were returned to the manufacturer for analysis. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, 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. Analysis of the returned lead portion confirmed discontinuity of the negative quadfilar coil in the electrode region. The abraded openings found on the outer silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.

 
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 Key4161859
Report Number1644487-2014-02621
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 09/11/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2011
Device MODEL Number302-20
Device LOT Number200772
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/14/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/19/2008
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: 10/10/2014 Patient Sequence Number: 1
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