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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

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CYBERONICS - HOUSTON LEAD MODEL 303 Back to Search Results
Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/16/2018
Event Type  Injury  
Event Description

It was reported that a patient was scheduled for a lead revision due to extrusion of the lead caused by the patient picking at his device. It was stated that the generator might also be replaced in case of infection. An update was received after the surgery occurred indicating that no revision or replacement occurred. It was stated that there was "wound dehiscence from a white tab", likely referring to a tie down. The wound was fine with no infection and was reclosed after removing the tie downs. Further clarification was then received that the devices were not visible through the wound, and that the incision site had just opened up as a result of the patient's picking. Device history records were reviewed for the lead product. The device was sterilized and passed all quality inspections prior to distribution. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 303
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7863106
Report Number1644487-2018-01590
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number303-30
Device LOT Number5322
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/12/2017
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: 09/11/2018 Patient Sequence Number: 1
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