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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/11/2015
Event Type  Injury  
Event Description

It was reported that the recently implanted vns patient was referred for surgery to clean the generator surgical wound site due to infection. No known surgical interventions have occurred to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

 
Manufacturer Narrative

Suspect device udi: (b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

Information was received from a physician's office that the patient will be re-implanted with a full system. The office believed that the generator and lead were previously explanted. A company representative confirmed that on (b)(6) 2015 the generator was moved to the right side and the lead was left in place. The patient had a very good response to vns and his parents did not want the system removed. He was unable to confirm that the patient was explanted.

 
Event Description

The patient was re-implanted on (b)(6) 2015. The vns system was explanted previously due to infection.

 
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Brand NamePULSE GEN MODEL 103
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 Key4909155
Report Number1644487-2015-05168
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/06/2016
Device MODEL Number103
Device LOT Number4130
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/25/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/29/2014
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: 07/13/2015 Patient Sequence Number: 1
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