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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

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CYBERONICS - HOUSTON LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/09/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluation not necessary due to the event not being related to delivery of therapy at all.

 
Event Description

Report was received that a patient started experiencing arrhythmia while under anesthesia. The patient was receiving a full revision surgery. After the new generator and lead were implanted, system diagnostics were run and showed high impedance (reported in mfr. Report #1644487-2017-04401). A second lead was tried but the surgeon had difficulty wrapping the electrodes around the nerve. The surgeon reported this was related to the vagus nerve being too big for the 2 mm lead used. This led to extended time under anesthesia. Due to this duration of surgery and the manipulation of the vagus nerve, the patient experienced arrhythmia. The anesthesiologist reportedly recommended that the surgery be terminated as a result. The generator was reportedly left implanted without any lead attached. Further information was received that the arrhythmia was not occurring with stimulation as it appeared about an hour after the last system diagnostic had been performed. It was also reported that the arrhythmia was benign. The lead passed all quality inspections prior to release for distribution. Device evaluation is not necessary due to the arrhythmia not being related to delivery of therapy. No further information has been received to date.

 
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Brand NameLEAD MODEL 303
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 Key6844458
Report Number1644487-2017-04402
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number303-20
Device LOT Number5070
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/10/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/27/2016
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: 09/06/2017 Patient Sequence Number: 1
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