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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 Premature End-of-Life Indicator
Event Date 07/01/2019
Event Type  Malfunction  
Event Description

It was reported that the patient's vns generator was already displaying an amber battery status (ifi) after a year of implantation. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The trim test tab was found to have occurred well after the discontinuation of the laser-routing manufacturing process. No additional relevant information has been received to date.

 
Event Description

It was reported that the patient was referred for vns replacement surgery. No relevant surgery is known to have occurred to date.

 
Event Description

The tablet data for the generator was received and reviewed by the manufacturer. Review of the data revealed that the event did not meet the criteria for beginning of life (bol) high battery impedance and, therefore, the alleged premature depletion cannot be attributed to bol impedance with the current data.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional tablet data was received by the manufacturer. The device was found to be pulse disabled due to battery depletion. Based on the data, the event still does not meet the criteria for bol high battery impedance and the premature depletion cannot be attributed to bol impedance.

 
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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 Key8833390
Report Number1644487-2019-01463
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/07/2020
Device MODEL Number106
Device LOT Number204383
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/16/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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