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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 11/09/2016
Event Type  Injury  
Event Description

It was reported that a physician disabled a patient's generator because the patient was experiencing "too much chest wall pain with radiation into her left arm. " the physician programmed the normal output current off, but left the magnet output programmed on. No additional intervention has been taken for the patient's pain. The painful stimulation started about a month prior to the report. Diagnostics were within normal limits at the patient's last two office visits. The patient's settings were adjusted at the last office visit, so the diagnostics were performed after the painful stimulation began. Later follow-up was received (b)(6) 2017 from the surgeon's office that the patient was referred by the neurologist for explant of the device as the patient seemed unwilling to accept the side effects. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Manufacturer Narrative

The incorrect patient code was inadvertently provided on the initial report.

 
Manufacturer Narrative

Corrected data: the type of report field was inadvertently not marked as ¿follow-up#¿1 on follow-up report#1. Corrected data: the date reported to manufacturer was inadvertently provided as 11/10/2017 on follow-up report #1 when it was intended to be provided as 12/05/2017.

 
Event Description

Information was received from the physician regarding the reported events. The patient¿s seizures did not worsen on vns, but instead the patient was a nonresponder to treatment. The patient reported pain in their chest at their last appointment, however the device was not disabled as the magnet mode has remained on. Surgery is likely but has not occurred to date. No additional information has been received.

 
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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 Key6996132
Report Number1644487-2017-04716
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/18/2017
Device MODEL Number106
Device LOT Number203808
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2016
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: 11/02/2017 Patient Sequence Number: 1
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