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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 12/05/2014
Event Type  Injury  
Event Description

It was reported on (b)(6) 2015 that the patient experienced dizziness just before the device turns on and if she is standing she feels as if she will pass out. The onset of this event was about 3-4 weeks prior to the report ( (b)(6) 2014). The patient was initially implanted on (b)(6) 2014 and the neurologist last increased her normal mode output to 1. 25 ma. The patient also reported burning in the epigastric region during stimulation. Diagnostics were normal. Additional information received indicated that the patient alleged that her device was stimulating more frequently than every 5 minutes as it was set to do. The patient put a magnet in place to disable the device, and went to urgent care for treatment. Further information was received indicating that the pulse generator had been disabled. X-rays were taking with no remarkable findings by the medical professional. No surgical intervention has occurred to date.

 
Manufacturer Narrative

 
Event Description

Further information was received that the patient's generator had been turned back on. Shortly after being turned back on, the patient reported experiencing nausea and painful stimulation in her stomach. The patient reported having the pre-existing condition of gerd, an acid reflux disorder, which was exacerbated by the vns stimulation. The patient was later seen by her physician who performed system diagnostics. The results were normal. The physician indicated the stimulation was exacerbating the gerd. No other relevant information has 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 Key4468523
Report Number1644487-2015-03713
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2016
Device MODEL Number103
Device LOT Number202919
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/05/2014
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: 01/30/2015 Patient Sequence Number: 1
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