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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
Device Problem High impedance
Event Date 08/03/2015
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

Clinic notes were received indicating that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015. It was noted that the patient's seizures were fairly controlled at that time. The patient returned to the office on (b)(6) 2015. The patient's mother indicated that the patient's seizures had gotten worse. The patient's medication was subsequently increased. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

Additional information was received stating that during generator and lead replacement surgery on (b)(4) 2015, the surgeon was unable to complete the procedure due to fibrosis around the electrode site and the patient's anatomy. The replacement generator was tested to the existing lead and diagnostic results continued to show a high impedance condition. The surgeon opened up the neck incision site but was unable to explant the lead electrodes from the patient's vagus nerve due to fibrosis. The surgeon noted that the patient's vagus nerve was "tangled and bundled with other nerves" above the electrode site and was unable to locate an implant location for the replacement lead. The patient's generator was explanted along with a portion the lead. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. The patient has not been re-implanted to date.

 
Event Description

Additional information was received stating that the patient was re-implanted on (b)(6) 2015. The generator and lead were placed on the right side of the patient's chest and vagus nerve.

 
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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 Key5104713
Report Number1644487-2015-05901
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 09/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2010
Device MODEL Number302-20
Device LOT Number200675
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2007
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: 09/25/2015 Patient Sequence Number: 1
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