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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 09/14/2010
Event Type  Malfunction  
Event Description

While reviewing internal programming history on the patient's vns generator, high impedance was noted on their normal mode diagnostic test with no corresponding system diagnostic test. Their treating physician reported that he was trying to contact the patient in regards to their high impedance but had been unsuccessful. He did not think that their vns therapy was effective therefore may not pursue further. No further information has been received in regards to their reported high impedance event.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Adverse event and/or product problem; corrected data: the previously submitted mdr inadvertently stated that the event was both an adverse event and product problem. The event is considered only a product problem. This mdr is being submitted to correct this data. Adverse event and/or product problem; corrected data: the previously submitted mdr inadvertently stated that the event was both an adverse event and product problem. The event is considered only a product problem. This mdr is being submitted to correct this data.

 
Event Description

Additional information was received stating that the vns patient¿s device was tested and system diagnostic results showed high impedance and a low battery condition. The patient¿s device was disabled but the patient subsequently began experiencing an increase in seizures. The patient declined to have his device replaced and no known surgical interventions have occurred to date.

 
Manufacturer Narrative

Adverse event and/or product problem; corrected data: additional information was received indicating that the event is both an adverse event and product problem.

 
Event Description

Clinic notes were received for patient. Notes indicate that the patient asked the device to be turned off due to his belief that the device presented him from sleeping. The device was turned a year later from implant per notes possibly due to sleep disturbance and lack of efficacy. Patient also experienced episodes of "blackouts" starting shortly after vns being turned off. Turning on vns again was discussed with the physician. There is no evidence of even temporary device disablement per programming history. No other relevant information was received.

 
Event Description

Patient underwent generator replacement due to battery depletion and unable to interrogate on (b)(6) 2016. The lead was not replaced and the high impedance was observed with the new generator with impedance of > 10000 ohms. The explanted generator was received on 08/03/2016. Analysis is underway but has not been completed to date. Patient underwent lead revision surgery on (b)(6) 2016. The explanted lead was cut in pieces and will not be returned to manufacturer.

 
Event Description

Analysis on the generator was completed. The alleged ¿eos¿, ¿failure to program¿ and ¿no stimulation¿ events were determined to be the result of normal battery depletion. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. The electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist and the eos condition is an expected event. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key2983415
Report Number1644487-2013-00549
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/31/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number302-20
Device LOT Number929
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2005
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: 02/28/2013 Patient Sequence Number: 1
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