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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS LEAD MODEL UNK

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CYBERONICS LEAD MODEL UNK Back to Search Results
Event Date 06/30/2015
Event Type  Injury  
Event Description

It was reported that the vns patient had presented acute vocal cord paralysis and shortness of breath. The patient was examined by an otolaryngologist and was referred for computerized tomography. It was reported that the events were suspected to be secondary to vns. The patient had had myocardial infarction previously. It was reported that the patient¿s generator was programmed at reduced pulse width and signal frequency, with an output current of 1. 25ma and a 44% duty cycle since 2011. It was reported that the patient was a good responder to vns therapy. Further information was received indicating that the vocal cord paralysis had debuted on (b)(6) 2015. There had been no changes in medication and the patient¿s settings had remained unchanged for a number of years. The patient does not have a previous history of vocal cord paralysis. It was reported that the medical professionals suspected that the myocardial infarction might have led to pulmonary embolism which, in turn, might have contributed to the event, and that a role of vns on the paralysis was believed to be unlikely. No known surgical interventions have occurred to date.

 
Manufacturer Narrative

 
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Brand NameLEAD MODEL UNK
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS
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 Key4934372
Report Number1644487-2015-05296
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/30/2015
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: 07/23/2015 Patient Sequence Number: 1
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