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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/23/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient experienced stridor and cyanosis while using their vns therapy magnet during a 56 minute long episode of continuous seizure activity. After the use of the magnet the patient continued to turn blue every five minutes for the duration of the seizure activity. A second magnet swipe during the seizure also produced temporary cyanosis. It was reported that while the patient typically had stridor/shortness of breath during seizures prior to vns implantation, that the stridor was more noticeable during the magnet swipes. Prior to and following this event, there were no other instances of cyanosis occurring with seizures. The patient had previously encountered minor stridor and shortness of breath events with magnet use during seizures but without complication. The physician decreased the patient's programmed generator settings. It was additionally reported by the patient's caregiver that when the magnet was placed over the device, to inhibit stimulation, the patient's symptoms seemed to resolve. It was reported that the patient's continuous seizure activity was not related to vns. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
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 Key8175737
Report Number1644487-2018-02335
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5667
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/16/2018
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: 12/18/2018 Patient Sequence Number: 1
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