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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Fracture
Event Date 08/09/2018
Event Type  Malfunction  
Event Description

It was reported that a patient¿s device is showing high impedance. It was reported the patient's seizure activity has increased and she sometimes feels a "zap" in her neck or chest. It was reported that her (b)(6) head-butted her in the chest. The patient was sent for an x-ray of the neck and chest however there were no lead breaks observed. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key7826426
Report Number1644487-2018-01517
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2018
Device MODEL Number304-20
Device LOT Number203022
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/29/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/12/2014
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: 08/29/2018 Patient Sequence Number: 1
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