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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 303

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CYBERONICS LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 12/21/2010
Event Type  Malfunction  
Event Description

On (b)(4) 2012 product analysis was completed on the vns patient's generator that had been explanted due to lack of efficacy. Product analysis revealed that the intensified follow-up indicator (ifi) was set to "yes". The intensified follow-up indicator (ifi) condition is uncharacteristic for the percentage of battery consumed value of 25. 940%. Further review revealed that the explanted generator was returned with the output current programmed to 1. 50 ma. The programming history shows a high (>= 10k ohms) impedance occurrence on (b)(6) 2010 and remained until received into decontamination on (b)(6) 2012 (generator output current programmed to 0. 0ma). The combination of a high impedance value and output current setting required a "vboost" compliance voltage that exceed the maximum compliance voltage capability for the device (>10. 5 v); longevity estimates are not guaranteed at compliance voltages greater than 10. 5v. In this situation a significant amount of additional current consumption exists, based on the need for a component to remain on (asic remains in a trickle charge state) in order to support the higher electrical load demand. This condition contributes to the disparity between the ifi condition and percent battery capacity that has been consumed, based on the device's internal eos projection system. Other than the noted error, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the programming history dated (b)(6) 2010 showed high impedance during a normal mode diagnostics test; output=low/lead impedance=high/current delivered=0. 75ma/impedance value=7210ohms/4. 4years. The patient was programmed to output=1. 5mafrequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. A system diagnostics test performed on (b)(6) 2011 also showed high impedance with output=low/current delivered=0. 25ma/lead impedance=high/impedance value>=10,000ohms/3. 3years and the patient was still programmed to output=1. 5mafrequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. Product analysis on the lead revealed that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. What appeared to be remnants of dried body fluids were observed inside one of the bilumen tubes. Good faith attempts for further information from the physician regarding the high impedance were made but were unsuccessful.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2856813
Report Number1644487-2012-03204
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/12/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/30/2009
Device MODEL Number303-20
Device LOT Number200280
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/19/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/12/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/10/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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