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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 Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Dysphasia (2195); Respiratory Tract Infection (2420); Electric Shock (2554)
Event Date 01/15/2014
Event Type  Injury  
Event Description
It was reported by the ent physician that the vns patient was seen in his office on (b)(6) 2014.Clinic notes were from the office visit were received indicating that diagnostic flexible fiberoptic laryngoscopy revealed left vocal cord paralysis possibly from a displaced lead.The notes also indicated that the patient recently went to the er where ct showed left vocal cord paralysis.The patient was having severe pain in her left throat and pain when swallowing.The ent physician suggests that the pain may possibly be due to a displaced lead, and advised the patient to have her generator programmed off.Additional information was received from the patient stating that she had been experiencing severe pain and had taped her magnet over her generator to disable stimulation.Whenever the magnet shifted out of place, the patient reported that she experiences a shock and the pain worsens.The patient was seen by a surgeon to discuss vns replacement.The surgeon believes that the patient does not have vocal cord paralysis but has irregular spasmodic movement of her left vocal cord which followed a severe upper respiratory tract infection.The surgeon stated that the patient¿s symptoms seem to worsen with vns stimulation.The surgeon does not believe that the reported event requires surgery, but suggested lowering the patient¿s settings.While the surgeon believes that the reported event is not due to vns, the neurologist believes there is a relationship with the reported event and vns.As suggested by the surgeon, the neurologist lowered the patient¿s settings.Review of the available programming and diagnostic history for the device did not reveal any anomalies.
 
Event Description
The patient's device was programmed back on as there was no difference in the spasmodic dysphonia with or without vns stimulation.No further relevant information has been received to date.
 
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Brand Name
LEAD, MODEL 302
Type of Device
LEAD
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 Key3658670
MDR Text Key4282836
Report Number1644487-2014-00577
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,company representative,hea
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2006
Device Model Number302-20
Device Lot Number010464
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 02/03/2014
Initial Date FDA Received03/04/2014
Supplement Dates Manufacturer Received03/06/2018
Supplement Dates FDA Received03/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
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