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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PUSLE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PUSLE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 03/04/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient had been picking at her incisions from her vns implant surgery. The incisions were slightly gaping as dehiscence wounds, and dermabond was applied to close the chest and neck incision sites. At the time of the initial report, the patient said that the incisions were healing and closed. There was no redness, oozing, or signs of infection at that time. Further information was received that the patient's neck incision was subsequently oozing pus, and the site was swollen red and painful. The symptoms began on (b)(6) 2016. The patient subsequently followed up with the surgeon's office for an appointment. She was treated with antibiotics to address a superficial infection. It was believed that the infection was also likely caused by patient influence at the surgical site. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional pertinent information has been received to date.

 
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Brand NamePUSLE GEN MODEL 106
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 Key5574698
Report Number1644487-2016-00764
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2017
Device MODEL Number106
Device LOT Number4661
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/16/2015
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: 04/13/2016 Patient Sequence Number: 1
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