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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 10/01/2012
Event Type  Injury  
Event Description

Date: settings [output current (ma)/ frequency (hz)/ pulse width (microseconds)/ on time (seconds)/ off time (minutes)/ magnet output current (ma)/ magnet pulse width (microseconds)/ magnet on time (seconds)]; diagnostics: [(normal mode) output status/ lead impedance; (system mode) output status/ lead impedance/ impedance value/ end of service?] : (b)(6) 2012: 0. 5/30/500/30/5; 0. 75/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2012: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/3200ohms/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2762ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2712ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2887ohms/no; (b)(6) 2013: 1. 0/25/500/21/1. 9; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2867ohms/no.

 
Event Description

It was reported that the patient was diagnosed with vocal cord problem that the ent attributes to vns therapy. It was reported that the patient experiences some difficulty breathing as a result of the vocal cord problem. Clinic notes dated (b)(6) 2013, note that the ent confirmed that vns discharges appear to be affecting the left vocal cord function, which may be compromising respiration in the context of his right-sided cyst. It was reported that device diagnostics were within normal limits. The physician may try to adjust device settings and then send the patient back to ent for reevaluation. Attempts to obtain additional information have been unsuccessful 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 Key3418880
Report Number1644487-2013-03255
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2013
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 Number3316
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/23/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/18/2013 Patient Sequence Number: 1
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