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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 05/19/2014
Event Type  Malfunction  
Event Description

Clinic notes were received indicating that the vns patient was experiencing an increase in seizures and was more irritable the past several weeks prior to the office visit on (b)(6) 2014. The patient¿s seizure frequency had improved with vns until the recent increase in seizures. The neurologist noted that the patient was having difficulty sleeping and physical stress from urinary problems which may have contributed to the increase in seizures. The patient¿s device was tested during the office visit and diagnostic results revealed high impedance. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

It was reported that the patient underwent generator and lead replacement. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device failure occurred (pitting), but did not cause or contribute to a death. Only a portion of the lead was returned for analysis; device failure is suspected in the lead portion not returned, but did not cause or contribute to a death.

 
Event Description

On july 24, 2014 product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. 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. Product analysis was completed on the lead on august 4, 2014. Although not conclusive, the location of a single setscrew mark noted in the vicinity of the connector pin end tip suggesting that the lead connector was not inserted completely (as received) may confirm this to be a contributing factor for the reported high impedance. A conclusive determination whether this condition existed during the implant life cannot be made. The lead connector was inserted completely in a pulse generator returned with the lead with no anomalies identified. Based in the location of one complete set of the setscrew marks noted on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator 쫝 and 쓝 terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. Scanning electron microscopy images of the discolored area noted on the connector ring shows that pitting or electro-etching conditions have occurred at this location. 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 mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
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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 Key3867577
Report Number1644487-2014-01477
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/19/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number302-20
Device LOT Number2311
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/24/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/11/2009
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: 06/11/2014 Patient Sequence Number: 1
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