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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 05/31/2018
Event Type  Injury  
Event Description

It was reported that during the lead replacement surgery for high impedance, which is reported in mfg. Report #1644487-2018-01042, an erratic heart rate was observed when the vns was programmed to the pre-op settings. The in-pocket vns diagnostics were within normal limits and heartbeat detection was verified within 1 beat per minute, or bpm, at 70 bpm. It was stated that there was slowing and increasing of the heart rate. The surgeon stated that this was likely the result of stimulation on a "fresh" portion of the nerve. It was decided to disable the vns and allow the patient's physician to titrate the device. No additional 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 Key7626459
Report Number1644487-2018-01047
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation Physician
Type of Report Initial
Report Date 06/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number106
Device LOT Number202553
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/02/2018
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: 06/21/2018 Patient Sequence Number: 1
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