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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 Problems Low impedance; Insufficient Information
Event Date 03/20/2019
Event Type  Malfunction  
Event Description

It was reported that low lead impedance of less than 600 ohms resulted from multiple system diagnostics tests although output current was ok and was successfully delivered at 1. 5ma. Additionally, the patient does have painful stimulation sometimes as well. The patient was referred for surgery. Follow up was performed with the patient's physician regarding the low impedance. It was reported that there is known trauma or manipulation of the vns area, the patient does not manipulate the lead themselves, and there is no change in stimulation perception reported by the patient. No known surgery has occurred to date. No additional or relevant information has been received to date.

 
Manufacturer Narrative

Corrected data, initial report: initial report inadvertently stated that there was known trauma or manipulation of the vns area instead of no known trauma or manipulation.

 
Event Description

It was reported that there is no known trauma or manipulation of the vns area.

 
Event Description

Patient underwent full revision (replacement of the lead and generator). The lead was replaced due to low impedance and the generator was replaced prophylactically. It was noted that a small tear on the lead and that it was unable to be determined if the damage occurred during removal. The explanted products have not been received by product analysis 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8515263
Report Number1644487-2019-00726
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/27/2019
Device MODEL Number304-20
Device LOT Number203452
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/03/2015
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: 04/15/2019 Patient Sequence Number: 1
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