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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fracture
Event Date 12/06/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that a patient experienced pain in the neck the chest and the left arm. The device was found to have high impedance. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Event Description

Full revision surgery occurred. Pre-operative diagnostics did not show high lead impedance but imaging did show the nerve was being pulled on by the lead. Imaging showed the nerve was almost at a 90 degree angle due to lead pulling on nerve. The explanted devices were discarded in surgery.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7134281
Report Number1644487-2017-05050
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2012
Device MODEL Number302-20
Device LOT Number2296
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/16/2009
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: 12/20/2017 Patient Sequence Number: 1
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