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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 02/24/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluated by manufacturer, additional information: device evaluation is not required for the reported event as it would not be suspected to provide additional relevant information for the reported event.

 
Event Description

It was reported that a patient had redness, pain, and swelling at her incision site a few weeks after surgery. The site was reportedly fine 7 days after surgery. The patient was administered antibiotics and was reportedly doing a little better. The patient then had an ultrasound performed and her site was still infected after the antibiotics. The manufacturing record for the implanted generator confirmed proper sterilization prior to release for distribution. No known surgical intervention has taken place 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 Key6484987
Report Number1644487-2017-03606
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2018
Device MODEL Number106
Device LOT Number203928
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/24/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/04/2016
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: 04/12/2017 Patient Sequence Number: 1
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