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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Clinical notes were received as part of the referral process for vns generator replacement. The notes stated that the patient's seizure activity had increased. The patient's neurologist believed this to be due to the device's battery being depleted and stated that the increase was above pre-vns seizure activity. Diagnostics were reported to be normal, but the specific results are not known at this time nor the exact status of the battery when the increased seizure activity began. The patient's generator was replaced. The generator will not be received for analysis as the explanting facility historically does not return explanted devices. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key7664143
Report Number1644487-2018-01141
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2011
Device MODEL Number103
Device LOT Number2497
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2009
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: 07/05/2018 Patient Sequence Number: 1
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