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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 Fracture
Event Date 03/12/2019
Event Type  Malfunction  
Event Description

The patient's neurologist had reported that they believed that the there was a lead issue as the impedance was around 800 ohms. It was explained to the neurologist that while the impedance is within normal limits, a representative would attend the surgery. While in surgery, the surgeon was able to see that the lead was exposed and the silicone cover was damaged, and the procedure was updated from a prophylactic generator replacement to a full revision. It was stated that there was a short circuit condition. The patient's lead and generator were replaced. The devices were not returned to livanova to date. No additional or 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 Key8470989
Report Number1644487-2019-00612
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/27/2017
Device MODEL Number304-20
Device LOT Number202462
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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