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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 06/13/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that since the patient's battery replacement surgery, she was experiencing neck pain. It was stated that right before her battery change due to battery depletion, she had a large seizure where after she felt a "pull in her neck". Since then, there had been a "lump" in her neck and pain with stimulation. She was going to obtain x-rays. There was no reported impedance issue. The patient stated that the vns helped her for years and that she would prefer to keep the device controlling her seizures rather than having it turned off for the pain. The physician did not know the cause of the lump and believed that an exploratory surgery or revision may be needed to know. It was clarified that this surgery would be for patient comfort, and not to preclude a serious injury per the physician's assessment. Diagnostics were indicated to have been within normal limits with ok battery life. X-rays were received for review. The connector pin was seen coming through the second connector block, indicating complete pin insertion. Based on the images provided, the cause of the painful stimulation could not be determined. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Clinic notes were later received. It was stated in the notes that the patient experienced painful stimulation, mainly in her neck, but associated with dysphagia, hoarseness, chest pain, and shortness of breath. The events are non-radiating and only occur with vns stimulation. The pain became so significant that the "voltage" (likely referring to output current) had to be decreased, with increased dosages of seizures meds and pain meds. It was stated that since decreasing settings and increasing meds, the patient stated that she was still getting 2-3 grand mal seizures per week. Further updates were received and the patient reported that she was "now having 2-3 seizures per day" and has very painful stimulation for which she is on medication for. Output current and duty cycle were lowered for the pain. The vns surgeon and breast surgeon agreed to wait to schedule vns surgery until after the patient's mastectomy. No known vns surgery has occurred to date. No additional, relevant information was 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 Key8621049
Report Number1644487-2019-00960
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5739
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/21/2018
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: 05/17/2019 Patient Sequence Number: 1
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