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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 08/05/2018
Event Type  Malfunction  
Event Description

It was reported that the patient presented in the er with painful stimulation. The pain was stated to be at the neck site for the patient. The patient's device showed that diagnostics were fine. The patient seems to have pain that is associated with magnet stimulation. The device was turned off until the patient can see the neurologist. The patient was then referred for replacement due to battery depletion and because of the new pain at left chest and left neck as the physician was worrisome for lead dysfunction. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

 
Event Description

Additional information was received that the patient was seen by the surgeon who stated the pain was most likely related to a muscle strain so no surgery was scheduled and the patient was referred back to the neurologist.

 
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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 Key7842396
Report Number1644487-2018-01555
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/12/2012
Device MODEL Number103
Device LOT Number2862
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/01/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/03/2010
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: 09/04/2018 Patient Sequence Number: 1
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