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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 06/11/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value = 10,000 ohms). The patient¿s device was not disabled. The patient was last seen in d(b)(6) 2013 and lead impedance was within normal limits at the time. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. No known surgical interventions have occurred to date.

 
Event Description

It was reported that the patient had generator and lead replacement surgery. It was reported that the surgeon found tissue leaking into the lead tubing. The suspect device was returned to the manufacturer for analysis. However, analysis has not been completed to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

Analysis of the generator and lead was completed. 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. The reported fluid leaks in the lead was verified. A puncture opening was noted on the outer silicone tubing. The exact point in time of when the puncture occurred (implant or explant) cannot be determined. Also, an abraded opening in the inner silicone tubing of one of the lead coils, exposing conductive quadfilar coils, was noted at the second portion of the returned lead. Note that since a portion of the lead (including the electrode array) 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 in the returned lead portions. Additional information was received from the treating physician. It was reported that the increased seizures were not reported to the office, but were probably due to high impedance. They increased seizures were reportedly back to pre-vns seizrue frequency level. No other interventions were taken except replacement surgery.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient's seizures have increased in frequency.

 
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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 Key3916681
Report Number1644487-2014-01705
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/11/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2009
Device MODEL Number302-20
Device LOT Number1598
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/07/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/21/2006
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: 07/07/2014 Patient Sequence Number: 1
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