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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Injury  
Event Description

It was reported that the patient experienced painful stimulation/shocking in the neck when the magnet was swiped over the generator and their pain management physician requested information about explanting the patient's generator. It was reported that the patient had been strangled and that the nurse believed the patient's lead may be broken due to the reported assault. It was additionally reported that the patient's lead was bent and was "poking out. " clarification from the medical professional indicated that the device was not coming out of the skin. The patient no longer felt the vns cycle like she had in the past. No known surgical intervention has occurred to date. No further relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
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 Key8302654
Report Number1644487-2019-00221
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/07/2018
Device MODEL Number304-20
Device LOT Number202771
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2014
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: 02/04/2019 Patient Sequence Number: 1
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