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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 1000 GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury  
Event Description

It was reported that the patient underwent a full vns explantation surgery. It was noted that the patient was "a picker. " follow up with the patient's neurologist revealed that the patient was explanted due to a post-operative hematoma that compromised the patient's respiratory airway. A review of device history records revealed that both the lead and generator were sterilized prior to distribution. The explanted products were received by the manufacturer and are pending product analysis. The explant data form received with the products indicated that a dehiscence wound was present at the generator site. No additional relevant information has been received to date.

 
Event Description

Follow up with the physician's office revealed that the hematoma occurred immediately after the patient's initial vns implantation surgery and the patient went back to the or from recovery. The nurse believed that the event was related to the surgery as the patient was not seen scratching the area. It was stated that the patient's neck had started swelling and the patient had airway issues. The surgery was reported as to also control the bleeding. An infection was present and the cultures came back as mrsa. The patient returned to the clinic later as the wound was open and exposed. The patient's vns leads were reportedly exposed and infected. It was confirmed that the patient's lead site was infected and that the cultures had come back as mrsa. Generator product analysis completed. Proper functionality of the generator was successfully verified in the pa lab. The generator was placed in a simulated body temperature environment and was monitored for more than 24 hours. No signs of variation in the output signal were observed. The diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance or other adverse conditions found with the generator. Lead product analysis was completed. The lead assembly was returned for analysis with the lead connector still inserted in the pulse generator header. A continuity check verified that proper contact between the set-screw and lead pin was present. The condition of the lead electrodes were consistent with those typically following explant. Other than typical wear/explant related observations, no anomalies were identified with the returned lead.

 
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Brand NamePULSE GEN MODEL 1000
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 Key8081287
Report Number1644487-2018-02079
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000
Device LOT Number204555
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/23/2018
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: 11/16/2018 Patient Sequence Number: 1
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