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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2019
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr? 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 this patient has a wound infection of the left axilla. Additional information was received that the patient first presented with the infection with an aching in their left axilla. The majority of the infection was located at the wound site, but the physician thinks the infection expanded to the generator area, but the wound site was not open. It was stated that this patient has diabetes with poor glycemic control, and therefore is at increased susceptibility to infection. Therefore the physician thinks the bacteria might be penetrated from the wound site at the left axilla and expanded to the generator area. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No known surgical intervention has occurred to date. No further relevant information has been received to date. 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.

 
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Brand NamePULSE GEN MODEL 103
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 Key8424229
Report Number1644487-2019-00506
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/15/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/19/2018
Device MODEL Number103
Device LOT Number5126
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/12/2016
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: 03/15/2019 Patient Sequence Number: 1
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