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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

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LIVANOVA USA, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/21/2000
Event Type  Injury  
Event Description

Clinic notes were received indicating that during the vns placement the nerve on the right was nicked. Additional relevant information has not been received to-date.

 
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Brand NameBIPOL LEAD MODEL 300
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 Key7877120
Report Number1644487-2018-01613
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/02/1999
Device MODEL Number300-20
Device LOT Number29278C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/30/1999
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: 09/14/2018 Patient Sequence Number: 1
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