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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/29/2019
Event Type  Injury  
Event Description

It was reported through clinic notes that the patient's vns battery status was 11-25% remaining,, so he needed to have a generator replacement soon. It was then indicated that the surgeon would need to be notified as the patient's seizures were increased. It was then reported that the increased seizures was how the mother knew that the battery was low. It should be noted that the patient's generator is designed to provide it's intended therapy until it's fully depleted, at which point the generator disables itself. High impedance was not reported. No known surgical intervention has occurred to date. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8659874
Report Number1644487-2019-01060
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/20/2014
Device MODEL Number105
Device LOT Number202279
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/23/2012
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: 05/31/2019 Patient Sequence Number: 1
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