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U.S. Department of Health and Human Services

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

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

 
Event Description

It was reported that a patient's generator and lead were explanted due to infection and wound breakdown with no immediate replacement. Further clarification was received that the infection was at the vns generator site and the wound had stated to dehisce. The explanted devices were returned. It was further stated that the patient had been in-patient for 4 days with glucose readings of over 400 mg/dl every night. The surgeon stated that the glucose being uncontrolled was a contributing factor to the infection. Device history records were reviewed for the implanted devices and were noted to have been sterilized and passed all quality inspections prior to distribution. No additional relevant information was received to date.

 
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Brand NamePULSE 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8241440
Report Number1644487-2019-00049
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5710
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/26/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/18/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/26/2018
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: 01/11/2019 Patient Sequence Number: 1
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