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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Detachment Of Device Component
Event Date 08/21/2010
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was undergoing generator replacement surgery when the surgeon identified abraded openings in the lead tubing (reported in mfr. Report #1644487-2018-00663), so a lead revision was then performed. It was then identified that there was no strain relief, and the electrodes were detached from the nerve. The surgeon and ear, nose, and throat specialist stated that the nerve was bubbled and severely scarred from the electrodes rubbing on it. The impedance was within normal limits prior to the surgery, which indicated that the electrodes were in contact with patient tissue while implanted. It was believed that the electrodes rubbed against the nerve after becoming detached, which caused the damage to the nerve. The lead was received by the manufacturer, and analysis was performed (reported in mfr. Report #1644487-2018-00663). However, the electrode portion of the lead was not returned, so no analysis could be performed on the portion of the lead relevant to this report. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 302
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 Key7467612
Report Number1644487-2018-00664
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/09/2014
Device MODEL Number302-20
Device LOT Number2658
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2010
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: 04/26/2018 Patient Sequence Number: 1
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