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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 01/03/2015
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (6592 ohms). Previous device diagnostics on (b)(6) 2015 were within normal limits (2736 ohms). X-rays were taken and did not identify any obvious discontinuities with the vns system. The generator was programmed off and the patient was referred to surgeon. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that the patient is undergoing ent procedures to treat painful stimulation in the neck and head, voice alteration, and coughing that he has been experiencing since early january. However, the device being disabled has also helped diminish these symptoms as they were thought to be related to stimulation during high impedance. No known vns surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received that the patient underwent a recent brain surgery and the vns is still disabled. The patient's previous neurologist has no additional information to provide. No known surgical interventions have occurred to date.

 
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Brand NameLEAD MODEL 304
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 Key4516986
Report Number1644487-2015-03836
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/21/2014
Device MODEL Number304-20
Device LOT Number201584
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/21/2010
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: 02/13/2015 Patient Sequence Number: 1
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