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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 302-30
Device Problem Positioning Problem
Event Date 09/03/2015
Event Type  Malfunction  
Event Description

It was reported that the patient was having pain at her vns generator implant site and thus was wanting the device repositioned. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

 
Event Description

Additional information was received that the patient was hyper-sensitive to the pain, so initially it was believed that there was nothing wrong other than the presence of the device causing pain. It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 due to the chest pain as well as painful stimulation. Pre-operative diagnostics revealed normal impedance of 1,590 ohms. During the replacement surgery, the surgeon observed a crack in the lead insulation with some fluid inside. There was no known trauma which caused this. The lead was not revised.

 
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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 Key5106217
Report Number1644487-2015-05903
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2009
Device MODEL Number302-30
Device LOT Number200104
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2006
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: 09/26/2015 Patient Sequence Number: 1
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