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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 Fracture
Event Date 03/14/2012
Event Type  Malfunction  
Event Description

During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed on (b)(6) 2012. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. The device was not programmed off after observing the high impedance reading. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Additional information was received stating that the vns patient¿s device was tested and diagnostic results showed high impedance. X-rays were taken and were reported by the physician to be unremarkable. The patient underwent surgery on (b)(6) 2014. Upon opening the neck incision site, an abundant amount of fibrosis was observed and the surgeon determined that surgery could not continue so the patient was closed. No known surgical interventions to resolve the reported high impedance have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

An article titled "resultados de la estimulación del nervio vago en pacientes con epilepsia farmacorresistente en un centro de referencia nacional de epilepsia" ( results of vagal nerve stimulation in patients with drug-resistant epilepsy at a national referral center for epilepsy) was received and provided additional information for this patient. The patient was noted to have had a new vns device implanted on the right vagus nerve after the extensive fibrosis was found on the left vagus nerve. The replaced lead has not been sent to the manufacturer to date and the exact date of the surgery has not been noted to date. No further relevant information has been received to date.

 
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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 Key3404837
Report Number1644487-2013-03119
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number302-20
Device LOT Number1346
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/28/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/17/2005
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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