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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 Under-Sensing
Event Date 03/01/2019
Event Type  Malfunction  
Event Description

It was reported that the patient was admitted to the hospital for seizures. It was stated that the patient's new vns generator was programmed to the patient's previous vns' settings and that there were no autostim detections. The physician increased the autostim sensitivity parameter. It was unknown if the physician was attributing the increase to the vns generator's lack of autostim detections. The patient's previous vns generator had issues with detecting tachycardia events for autostim as well. The previous generator was received by the manufacturer and is pending product analysis. 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8471156
Report Number1644487-2019-00629
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5972
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/30/2018
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: 04/01/2019 Patient Sequence Number: 1
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