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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 09/26/2018
Event Type  Injury  
Event Description

It was reported that the patient experienced apnea after a replacement when the newly implanted generator's settings were programmed to the settings on the previous generator. When this occurred, the patient started having apnea where she would stop breathing for 30 seconds at a time (same as on time). Once the patient's device was off and no longer providing stimulation she was able to breath like normal. This occurred while the patient was still in the operating room. The generator was then programmed off. The patient had no history of apnea. The patient later had the generator turned back on and titrated to lower settings. The patient has had no apnea since the return of stimulation. Per the physician, a combination of vns stimulation and anesthesia contributed to the apnea. The patient reportedly only had apnea at 3ma output current. After the cessation of anesthesia and turning the generator off, they were able to titrate the patient back to the lower settings without issue.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7981071
Report Number1644487-2018-01855
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2018
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: 10/18/2018 Patient Sequence Number: 1
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