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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 08/29/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2012, it was reported that the patient was experiencing painful stimulation in the neck area for the last day or so. X-rays were taken, and no lead issue was seen. The x-rays would not be sent to the manufacturer for review. High lead impedance was seen the day before and the patient's device was disabled late on (b)(6) 2012, or early on (b)(6) 2012. The patient underwent surgical consult. The patient was reported to have been seizure-free for three years, and there was no reported increase in seizures. There was no known trauma. On (b)(6) 2012, the patient reported that, during interrogation earlier in the day, an error message popped up which said that her leads are detached or there is tissue build up. The patient stated that x-rays were taken but did not show any detachment. The patient stated that the device was programmed off and that she was referred for lead replacement due to the detachment issue. The patient stated that there had been no trauma or manipulation that she was aware of; however, she occasionally lifted heavy things. The generator and lead were replaced on (b)(6) 2012. X-rays were observed prior to surgery and a definitive lead break was observed in the lead just above the bifurcation. During surgery, it was noticed that the electrode coils appeared to be pulling off of the nerve but that they were scarred in tightly. The patient's generator was replaced prophylactically. The lead and generator were returned on (b)(4) 2012 and are currently undergoing product analysis. A battery life calculation on (b)(4) 2012, resulted in 7. 67 years to neos.

 
Event Description

Product analysis for the explanted generator was approved on (b)(6) 2012. The device performed according to functional specifications. Analysis of the generator in the (b)(4) lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the explanted lead was approved on (b)(6) 2012. The electrodes of the lead were not returned for product analysis. Setscrew marks on the connector pin provided evidence that proper contact between the setscrew and lead pin existed at least once. Abrasions were identified on the outer silicone tubing at multiple locations and on the connector boot. The outer silicone tubing had cuts at several locations. Some cuts did reach the inner silicone tubing. Abrasions were identified on the silicone tubing of the lead coils. The silicone tubing of the positive coil appears to be abraded and open in the vicinity of the coil end. It is believed that this condition could potentially contribute to the patient "pain" allegation. However, the exact impact of this condition and when it occurred is unknown. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred in the vicinity of the coil cut end. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified within the returned lead portion.

 
Manufacturer Narrative

Analysis of programming history. Device failure is suspected but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

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

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2758863
Report Number1644487-2012-02223
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number302-20
Device LOT Number2161
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/18/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/02/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/26/2008
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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