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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102R GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/08/2018
Event Type  Malfunction  
Event Description

Vns was discussed with a patient who was wondering how long a generator lasts before needing replacement. In discussing the signs of low battery, the patient noted that he has experienced some increased seizure activity. The patient was encouraged to check with his physician to determine when the vns was last checked. A battery life calculation was performed on the device, and did not confirm battery depletion with the programming history available. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102R
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 Key7651865
Report Number1644487-2018-01108
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/07/2015
Device MODEL Number102R
Device LOT Number202600
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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