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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient had an episode where he experienced choking, and puking which he explained as a sensation that the generator was continually in magnet mode. He also reported a tingling sensation in his left arm associated with stimulation. X-ray images were reviewed and repealed no relevant information regarding the events. Additional clinic notes were received indicating that the patient reported that he experienced choking and shortness of breath sometimes. He felt scared during sleep. Patient complained of choking, shortness of breath, neck pain radiating left upper extremity. It occurred once in 10-15 minutes. In addition, he complained of pain in left chest and one episode of numbness in the left arm. The normal output current was disabled and magnet mode was left on. The physician notes that there was no abnormality on x-ray. The physician tried lowering the output current and adjusting the frequency, pulse width and duty cycle but the patient could not tolerate. Therefore the normal output current was disabled while leaving the magnet output current on. Patient has no symptoms when the device is disabled. No other contributory or casual events that preceded the reported events. The neurologist plans to refer patient to neurosurgery for a consult in regards to the electrode placement on the nerve. No known surgical interventions have occurred to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6695583
Report Number1644487-2017-04118
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203826
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/15/2016
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: 07/07/2017 Patient Sequence Number: 1
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