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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 11/06/2016
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Report received that a patient's generator and lead were explanted due to an infection. This occurred about 14 months after the initial implant. Further information was provided from the explanting surgeon that, at the time of the explant, the patient presented with wound dehiscence and an open pocket. The generator was reportedly seen coming out of this open wound with pus. There was reportedly no note of the patient picking at the generator. A review of the generator's device history record indicated it had been properly sterilized prior to release for distribution. No further 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 Key7304683
Report Number1644487-2018-00303
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/29/2017
Device MODEL Number106
Device LOT Number203490
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 Received02/05/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/26/2015
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: 02/28/2018 Patient Sequence Number: 1
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