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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/14/2018
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported by a physician that a patient was interrogated and found to be set to 0 milliamps for all output currents unexpectedly. The patient underwent an ekg about a week prior to visiting the doctor and it was stated that the ekg electrodes were placed over the device. The patient's parent reported an increase in seizure activity and the physician believes that a generator reset occurred. A review of the downloaded data was performed and it was identified that generator hardware resets had occurred on the device on (b)(6) 2017, (b)(6) 2017, (b)(6) 2018, (b)(6) 2018, and (b)(6) 2018 and the output current had been set to 0 milliamps. The cause for the reset could not be determined from review of the data. Additional relevant information has not been received to-date.

 
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Brand NamePULSE GEN MODEL 103
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 Key7939028
Report Number1644487-2018-01777
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation Physician
Type of Report Initial
Report Date 11/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date05/15/2017
Device MODEL Number103
Device LOT Number203431
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/22/2015
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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