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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 11/12/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.

 
Event Description

It was reported that the patient presented with post-surgical fever, edema in the thoracic region and was treated with antibiotics without results. It was reported that the generator was explanted due to infection at the generator site. The hospital that performed the surgery has been closed due to an increase in hospital infection. Device history records were reviewed for the generator and lead. The devices passed all specification tests and were sterilized prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. 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 - 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 Key8233101
Report Number1644487-2019-00008
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number204470
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age5 mo
Event Location Other
Date Manufacturer Received12/18/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/07/2018
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: 01/10/2019 Patient Sequence Number: 1
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