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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/26/2018
Event Type  Injury  
Event Description

It was reported that the patient experienced an increase in seizure frequency and was referred for generator replacement surgery. The company representative reported that the patient's settings were high, in reference to their referral for generator replacement. The patient's implant card indicated that the generator replacement was prophylactic. Prior to the replacement surgery the patient's lead impedance was within normal limits. The suspect product has not been received to date. No further relevant information has been received to date.

 
Event Description

Incoming communication indicated that the patient's physician reported that the relationship between the patient's increase in seizure frequency and the vns was unclear. It was reported that the increased was possibly due to vns battery being low, and the patient's guardian believes this. The physician reported that the increased seizure rate was not worse than the pre-vns baseline and that there had been no medication changed. The suspect product has not been received to date. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key8177102
Report Number1644487-2018-02340
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/19/2019
Device MODEL Number106
Device LOT Number204340
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/31/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/16/2018
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: 12/18/2018 Patient Sequence Number: 1
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