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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Insufficient Information
Event Date 01/24/2017
Event Type  Malfunction  
Event Description

It was reported to a company representative that the patient had fallen from a seizure a few weeks ago. Diagnostics were reported to be ok. The patient reports an increase in seizures. The patient was referred for exploration/revision surgery, however no surgery has been planned or known to have occurred to-date. Follow-up from the company representative provided that the physician does believe the device is malfunctioning likely due to the fall the patient had, and that there was an increase in seizures. The increase in seizures is not worse than before vns, and was not caused by vns. Additional relevant information has not been received to-date.

 
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Brand NamePULSE GEN MODEL 102
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7560796
Report Number1644487-2018-00905
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/26/2017
Device MODEL Number102
Device LOT Number203653
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/14/2015
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: 06/01/2018 Patient Sequence Number: 1
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