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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 07/31/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, a nurse practitioner reported that the vns patient's leads were implanted on the right vagus nerve instead of the left. On (b)(6) 2012, the surgeon reported that he could not find any place on the left vagus nerve to place the lead, therefore it was placed on the right vagus nerve. They turned on the device shortly after surgery and programmed the patient to an output current of 2. 0 ma and the patient started experiencing more spasms. The patient's output current was then lowered to 0. 25 ma. Then when the settings were increased up a level, the patient started having spasms again. The surgeon stated that he was considering taking the patient back to surgery as he was wondering if the patient's spasms were due to the lead placement. The surgeon then later reported that he did not think he could get another lead on the left side so they went for right side replacement even though he knows the manufacturer's labeling is for left side placement only. With the device on the left side the patient was able to tolerate settings of up to 2. 5 ma. However, once placed on the right side the patient was only able to tolerate a setting of 0. 25 ma. A setting of 0. 5 ma, which is what the magnet mode was set to, resulted in the patient experiencing significant laryngospasms. The patient was not scoped to make sure it was contraction of the laryngeal cord causing the issue and not something else as the surgeon did not think it was necessary since swiping the magnet, set to 0. 5 ma, resulted in significant choking. The nurse stated that the patient immediately had adverse events with stimulation as the patient had been programmed to his original settings of 2. 0ma without giving the nerve a chance to acclimate to the stimulation. The patient is now being titrated up slowly and all his adverse events have stopped. The nurse later reported that after surgery on (b)(6) 2012, was the first time the laryngospasms/coughing were first observed. The nurse believes that it is due to the high stimulation from vns being turned on to 2. 0 ma after surgery. The events occurred with stimulation. Diagnostic results were within normal limits but the specifics were not provided. The patient does not have a medical history of laryngospasms prior to vns. The laryngospasms ceased after turning the settings down.

Manufacturer Narrative

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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2713825
Report Number1644487-2012-02126
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number304-20
Device LOT Number3322
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 08/24/2012 Patient Sequence Number: 1