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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 1000 GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury  
Event Description

It was reported that the patient experienced fits of screaming and crying upon the introduction of the auto-stimulation feature. The fits continued once auto-stimulation was turned off. The patient's generator was disabled, all output currents set to 0 ma, according to a company representative. It was reported that the patient continued to intermittently scream and cry when the device was disabled. It was reported that the patient's system diagnostics were within normal limits. It was reported that the patient's physician indicated that the increased output current may have caused inflammation or swelling. It was additionally reported that the adverse events began with the introduction of auto-stimulation and that the patient was prescribed steroids. A review of the manufacturer's device history records indicated that the generator passed functional specifications prior to distribution. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 1000
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 Key8246320
Report Number1644487-2019-00069
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204644
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2018
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: 01/14/2019 Patient Sequence Number: 1
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