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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 04/07/2011
Event Type  Injury  
Event Description

It was initially reported by a physician that a pt was having laryngeal spasms, which had required her hospitalization in the past. At this time, the pt had 3 spasms and the pt turned cyanotic. The pt's vns physician turned the output current down from 2. 5 ma to 2. 0 ma, stopping the spasms. The pt was reported to be "doing better" after the change in parameters. Further info was received from the physician, which stated the spasms did correlate with the vns stimulation, but the pt "was having other issues going on, too". Consequently, it was difficult for the physician to say what was causing the effect exactly. Diagnostic results were not available from the site, there were no other factors that could have contributed to the event, and the pt did not have a history of this event prior to vns. However, the site then claimed the relationship to vns for this event was not known. The site claimed that the pt's mother was going to "see what happens" at the lowered setting and re-evaluate at a later time. A search of the mfr's programming history database revealed that last known diagnostics on (b)(6) 2011 were within normal limits.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2098645
Report Number1644487-2011-01028
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number103
Device LOT Number2355
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/11/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2009
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: 05/11/2011 Patient Sequence Number: 1
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