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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/31/2017
Event Type  Injury  
Event Description

It was reported that a vns patient needs to have her vns replaced because her pocket incision had opened and the site was infected. Follow-up to the physician provided that the wound had healed fully post-surgery. He thought the wound opened because the carehome physically lifts the patient on a regular basis. He believed the way they were lifting her caused the device to wear away the skin at the incision site, causing it to open and become infected. Review of manufacturing records provided the devices were sterilized prior to distribution. Additional relevant information has not been received to-date.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
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 Key6356632
Report Number1644487-2017-03260
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/15/2017
Device MODEL Number104
Device LOT Number4245
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/23/2015
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: 02/24/2017 Patient Sequence Number: 1
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