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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient who was recently implanted has a golf ball sized lump over his generator. There is no redness or obvious signs of infection. The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder. The patient reported that the chest has become swollen like a golf ball. It is slightly warm to the touch, but not red. The patient saw the surgeon the surgeon decreased his output for the time being. It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep. The patient was advised not to bother the site and prescribed antibiotics. No additional relevant information has been received to date.

 
Event Description

Information was received indicating that the patient's lead came out of his neck incision. The physician's believe the patient has been picking at the site. It was indicated that the surgeon will be moving the patient's current vns system to his right side and checking lead integrity. The patient will also be placed on doxycycline for infection. Images were received that showed that the patient¿s lead is extruding out of his neck incision as well. No additional or relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6958245
Report Number1644487-2017-04640
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/18/2019
Device MODEL Number106
Device LOT Number5183
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2017
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: 10/18/2017 Patient Sequence Number: 1
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