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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

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CYBERONICS - HOUSTON BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2000
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The patient's generator was disabled after 6 months of use reportedly due to lack of benefit. It was reported that the patient's generator was explanted due to considerable irritation on the left site of their neck where the electrodes were located, which worsened when they turned their head. It was reported that prior to explant the patient's skin was puckered and that an anchor tether, part of the lead body, had poked through their skin. Another reason for explant was indicated as scar tissue, likely at the electrode site caused by chronic irritation. While the patient's generator was implanted they reported having tightened neck muscles due to vns stimulation, likely related to the lead extrusion and scar tissue. No further relevant information has been received to date.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8425064
Report Number1644487-2019-00512
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2002
Device MODEL Number300-20
Device LOT Number34945C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/09/2000
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: 03/15/2019 Patient Sequence Number: 1
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